81_FR_10593 81 FR 10553 - Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories

81 FR 10553 - Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 40 (March 1, 2016)

Page Range10553-10557
FR Document2016-04411

The Food and Drug Administration (FDA, Agency, or we) is proposing to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls). FDA is identifying proposed special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is publishing in this document the recommendations of the Blood Product Advisory Committee regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these device types.

Federal Register, Volume 81 Issue 40 (Tuesday, March 1, 2016)
[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Proposed Rules]
[Pages 10553-10557]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04411]



[[Page 10553]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 864

[Docket No. FDA-2016-N-0406]


Medical Devices; Hematology and Pathology Devices; Classification 
of Blood Establishment Computer Software and Accessories

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
proposing to classify the blood establishment computer software (BECS) 
and BECS accessories into class II (special controls). FDA is 
identifying proposed special controls for BECS and BECS accessories 
that are necessary to provide a reasonable assurance of safety and 
effectiveness. FDA is also giving notice that the Agency does not 
intend to exempt BECS and BECS accessories from premarket notification 
requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act). FDA is publishing in this document the recommendations of the 
Blood Product Advisory Committee regarding the classification of these 
devices. After considering public comments on the proposed 
classification, FDA will publish a final regulation classifying these 
device types.

DATES: Submit either electronic or written comments by May 31, 2016. 
Please see section IV of this document for the proposed effective date 
of a final rule that may issue based on this proposal.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0406 for ``Medical Devices; Hematology and Pathology 
Devices; Classification of Blood Establishment Computer Software and 
Accessories.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Statutory and Regulatory Authorities

    The FD&C Act (21 U.S.C. 301 et seq.), as amended by the Medical 
Device Amendments of 1976, establishes a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of 
devices depending on the regulatory controls needed to provide 
reasonable assurance of their safety and effectiveness. The three 
categories of devices are class I (general controls), class II (special 
controls), and class III (premarket approval).
    Class I devices are those devices for which the general controls of 
the FD&C Act (controls authorized by or under sections 501, 502, 510, 
516, 518, 519, or 520 or any combination of such sections) are 
sufficient to provide reasonable assurance of safety and effectiveness; 
or those devices for which insufficient information exists to determine 
that general controls are sufficient to provide reasonable assurance of 
safety and effectiveness or to establish special controls to provide 
such assurance, but because the devices are not purported or 
represented to be for a use in supporting or sustaining human life or 
for a use which is of substantial importance in preventing impairment 
of human health, and do not present a potential unreasonable risk of 
illness or injury, are to be

[[Page 10554]]

regulated by general controls (section 513(a)(1)(A) of the FD&C Act). 
Class II devices are those devices for which general controls by 
themselves are insufficient to provide reasonable assurance of safety 
and effectiveness, but for which there is sufficient information to 
establish special controls to provide such assurance, including the 
issue of performance standards, postmarket surveillance, patient 
registries, development and dissemination of guidelines, 
recommendations, and other appropriate actions the Agency deems 
necessary to provide such assurance (section 513(a)(1)(B) of the FD&C 
Act). Class III devices are those devices for which insufficient 
information exists to determine that general controls and special 
controls would provide a reasonable assurance of safety and 
effectiveness, and are purported or represented for a use in supporting 
or sustaining human life or for a use which is of substantial 
importance in preventing impairment of human health, or present a 
potential unreasonable risk of illness or injury (section 513(a)(1)(C) 
of the FD&C Act).
    Under section 513(d)(1) of the FD&C Act, devices that were in 
commercial distribution before the enactment of the Medical Device 
Amendments of 1976 (1976 amendments), May 28, 1976 (generally referred 
to as ``preamendments devices''), are classified after FDA: (1) 
Receives a recommendation from a device classification panel (an FDA 
advisory committee); (2) publishes the panel's recommendation for 
comment, along with a proposed regulation classifying the device; and 
(3) publishes a final regulation classifying the device.
    FDA has classified most preamendments devices under these 
procedures, relying upon valid scientific evidence as described in 
section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c), to determine 
that there is reasonable assurance of the safety and effectiveness of a 
device under its conditions of use.
    Devices that were not in commercial distribution before May 28, 
1976 (generally referred to as ``postamendments devices''), are 
classified automatically by section 513(f) of the FD&C Act into class 
III without any FDA rulemaking process. Those devices remain in class 
III and require premarket approval, unless and until: (1) FDA 
classifies or reclassifies the device into class I or II or (2) FDA 
issues an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the FD&C Act, to a predicate device 
that does not require premarket approval.
    The Agency determines whether new devices are substantially 
equivalent to previously marketed devices by means of premarket 
notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 
360(k)) and part 807 of the regulations (21 CFR part 807).
    A person may market a preamendments device that has been classified 
into class III through premarket notification procedures without 
submission of a premarket approval application (PMA) until FDA issues a 
final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) 
requiring premarket approval.

B. Regulatory History of the Devices

    After the enactment of the 1976 amendments, FDA began to identify 
and classify all preamendments devices in accordance with section 
513(b) of the FD&C Act.
    The first BECS 510(k) premarket notification was cleared by FDA on 
August 26, 1996. Information Data Management, Inc., submitted premarket 
notifications for their Components & Distribution Information System 
and Donor Management Information System. These devices were compared to 
systems marketed prior to the 1976 medical device amendments, including 
the Blood Inventory Management System by Computer Sciences Corporation 
and the Donor Deferral Registry developed by the American National Red 
Cross. Between 1996 and December 2015, FDA has cleared 220 BECS and 
BECS accessories under the 510(k) program.
    In 1998, FDA sought recommendations from the Blood Product Advisory 
Committee (BPAC) serving as a Device Classification Panel on the 
classification of BECS. The Device Classification Panel recommended 
regulating BECS as a class II device with premarket review (Ref. 1). 
The classification of BECS was not finalized following the Device 
Classification Panel's recommendation in 1998 because of competing 
priorities.
    On December 3, 2014, the BPAC, serving as a Device Classification 
Panel (the Panel), again convened to discuss the classification of BECS 
and BECS accessories (Ref. 2). The Panel discussed the risks to health 
associated with BECS and BECS accessories, the classification of BECS 
and BECS accessories, and if classified as class II devices, the 
special controls that would be required for these devices. The Panel 
agreed that general controls were not sufficient to provide a 
reasonable assurance of safety and effectiveness of BECS and BECS 
accessories. The Panel believed that BECS and BECS accessories 
presented a potential unreasonable risk of illness, injury, or death, 
and that sufficient information exists to establish special controls 
for these devices. Consequently, the Panel recommended that these 
devices be classified into class II (special controls) with premarket 
review. FDA is not aware of new information that has arisen since this 
Panel meeting that would provide a basis for different recommendations 
or findings. The recommendations of the Panel are summarized in Section 
II.

II. Panel Recommendation

    This section summarizes the Panel's deliberations on December 3, 
2014.

A. Identification

    FDA proposed the following definition of BECS and BECS accessory to 
the Panel for their consideration: BECS and BECS accessories are 
devices used in the manufacture of blood and blood components to assist 
in the prevention of disease in humans by identifying unsuitable blood 
donors by: (1) Preventing the release of unsuitable blood and blood 
components for transfusion or for further manufacturing into products 
for human treatment or diagnosis; (2) performing compatibility testing 
between donor and recipient; and (3) performing positive identification 
of patients and blood components. A BECS accessory expands or modifies 
the function of the BECS and/or indications for use of the BECS device. 
These devices are intended for use with or capable of functioning with 
BECS for the purpose of augmenting or supplementing the BECS 
performance.

B. Recommended Classification of the Panel

    The Panel recommended that BECS and BECS accessories be classified 
into class II (special controls) with premarket review, and that FDA 
revise the proposed definition of a BECS accessory. The consensus of 
the Panel was that class II classification (special controls) and 
premarket review would provide reasonable assurance of safety and 
effectiveness of these devices and that there is sufficient information 
to establish special controls to provide such assurance for BECS and 
BECS accessories.
    The Panel considered the following valid scientific evidence to 
make their recommendations regarding the safety and effectiveness of 
the device under its conditions of use. Specifically, the Panel 
considered the history of safety and effectiveness of BECS and BECS 
accessories over many years of use in

[[Page 10555]]

blood establishments; the results of an FDA review of the scientific 
literature; medical device reports (MDRs) of adverse events or 
malfunctions; device recalls; and a summary of FDA's extensive 
inspectional and regulatory experiences with BECS and BECS accessories.
    The Panel also commented on the proposed definition of BECS 
accessories: ``A BECS accessory expands or modifies the function of the 
BECS and/or indications for use of the BECS device.'' These devices are 
intended for use with or capable of functioning with BECS for the 
purpose of augmenting or supplementing the BECS performance. The Panel 
recommended that FDA clarify which added functionalities would be 
considered a BECS accessory and, therefore, subject to regulations as a 
class II device with special controls.

C. Risks to Health and Special Controls

    As required by section 513(f)(1)(A) of the FD&C Act, FDA provided 
to the Panel the following summary of valid scientific evidence 
regarding the benefits and risks of BECS and BECS accessories. In the 
1990s, during establishment inspections, FDA investigators observed 
numerous problems with BECS, including software programs that posed 
significant risks to health, such as the potential for release for 
transfusion of blood and blood components found to be reactive when 
tested with assays for Human Immunodeficiency Virus. During the 
inspections, FDA found that unsuitable blood and blood components had 
been released and distributed as a result of improperly designed 
software.
    From 1996 to 2014, FDA received 201 MDRs for BECS and BECS 
accessories. The majority (86 percent) of the MDRs were for device 
malfunctions. In addition, one death and nine injuries were reported. 
The reported patient death was not attributed to the BECS. The 
information provided in the reports of the nine injuries was 
insufficient to accurately identify the nature of the injuries or the 
attribution to BECS. The remaining reports included events classified 
in various categories such as user error, operational problems, and 
labeling.
    Similarly, from 2006 to 2013, BECS manufacturers initiated 56 
voluntary device recalls. The deviations included programming errors, 
inadequate design requirements, and incorrect implementation of the 
design. The potential consequences of the BECS deviations included 
presenting donors with incorrect donor history questionnaires, failing 
to save certain test results in donor records, and failing to identify 
donors as deferred. The recalls were classified as class II and class 
III. A class II recall is a situation in which use of or exposure to a 
violative product may cause temporary or medically reversible adverse 
health consequences or where the probability of serious adverse health 
consequences is remote. A class III recall is a situation in which use 
of or exposure to a violative product is not likely to cause adverse 
health consequences. No recalls were classified as class I, a situation 
in which there is reasonable probability that the use of or exposure to 
a violative product will cause serious adverse health consequences or 
death.
    FDA presented the following risks to health associated with BECS 
and BECS accessories: (1) Transfusion reaction or death from the 
inadvertent release and transfusion of incompatible blood or blood 
components; (2) transfusion injury from the transfusion of inaccurately 
labeled and/or stored blood components; (3) transfusion injury or death 
from the release of blood components from otherwise ineligible donors 
(for example, the transmission of infectious diseases from the 
inadvertent release of blood components that have tested positive for 
transfusion-transmitted disease agents); and (4) donor injury from 
inappropriate or excessive donation of blood or blood components.
    FDA also proposed the measures described in table 1 to mitigate the 
risks to health associated with BECS and BECS accessories. The Panel 
agreed that the risks to health and mitigation measures identified by 
FDA and summarized in table 1 are applicable to BECS and BECS 
accessories.
    FDA next presented the following special controls for the Panel's 
considerations: (1) Software performance and functional requirements 
are provided in the premarket submission including detailed design 
specifications (e.g., algorithms or control characteristics, alarms, 
device limitations, and safety requirements); (2) verification and 
validation testing and hazard analysis are to be performed and provided 
in the premarket submission; (3) labeling includes software 
limitations, unresolved anomalies, annotated with an explanation of the 
impact on safety or effectiveness, revision history, and hardware and 
peripheral specifications; (4) traceability matrix performed and 
provided in the premarket submission; and (5) performance testing is 
performed and provided in the premarket submission, as necessary to 
ensure the safety and effectiveness of the system, and when adding new 
functional requirements, (e.g., electrical safety, electromagnetic 
compatibility, or wireless coexistence).
    The Panel members generally agreed with the special controls 
proposed by FDA. One Panel member commented that requiring the 
performance of verification and validation and hazard analysis is not 
sufficient without defining what type of testing is necessary, and 
expressed particular concern regarding the acceptable level of 
verification for BECS. Another member asked whether many of the 
proposed special controls should be considered general controls for the 
purposes of software manufacturing considering the evolution of 
technology.

     Table 1--Health Risks and Mitigation Measures for BECS and BECS
                               Accessories
------------------------------------------------------------------------
        Identified risks to health               Mitigation measures
------------------------------------------------------------------------
Transfusion reaction or death.............  Performance and functional
                                             requirements.
Transmission of infectious disease........  Performance and testing.
Donor health risk from too frequent or      Labeling.
 inappropriate donation.
------------------------------------------------------------------------

III. Proposed Classification and FDA's Findings

    After considering the recommendations of the Panel and the valid 
scientific evidence, including the published literature, MDRs, recall 
information, and FDA's extensive inspection and regulatory experiences 
with these device types (Ref. 3), FDA proposes to classify BECS and 
BECS accessories into class II (special controls) with premarket 
review. FDA believes general controls by themselves are insufficient to 
provide reasonable assurance of safety and effectiveness for these 
devices and that there is sufficient information to establish special 
controls to provide such assurance. FDA believes that special controls, 
in addition to general controls, would provide a reasonable assurance 
of the safety and effectiveness of BECS and BECS accessories and would, 
therefore, mitigate the risk to patients of transfusion reaction or 
death and transmission of infectious disease and risks to donors 
because of inappropriate donations.
    The special controls proposed for BECS and BECS accessories, 
specifically performance and functional requirements, device 
verification and validation, hazards analysis,

[[Page 10556]]

traceability, and performance testing, collectively ensure that the 
manufacturer performs and documents the activities necessary to 
decrease the risk of malfunction that could result in the adverse 
events noted above. Further, appropriate labeling ensures that the user 
of the device is provided clear instructions for use, including the 
limitations of the device, to reduce the risk of user error that could 
result in the risks to health associated with these devices.
    FDA has amended the proposed definition of BECS accessories 
consistent with the recommendation of the Panel and made other minor 
edits to the definition of BECS and the special controls presented to 
the Panel in the proposed regulation.
    Section 510(m) of the FD&C Act provides that a class II device may 
be exempted from the premarket notification requirements under section 
510(k) of the FD&C Act, if the Agency determines that premarket 
notification is not necessary to assure the safety and effectiveness of 
the device. The Agency does not intend to exempt BECS and BECS 
accessories from 510(k) premarket notification as allowed under section 
510(m) of the FD&C Act. FDA believes premarket notification is 
necessary for these devices to assure their safety and effectiveness.

IV. Proposed Effective Date

    FDA proposes that any final regulation based on this proposal 
become effective 30 days after its date of publication in the Federal 
Register.

V. Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
believe that this proposed rule is not a significant regulatory action 
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the proposed regulation is consistent with 
historical regulatory oversight given to this type of device, we 
propose to certify that the proposed rule will not have a significant 
economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    This rule proposes to classify BECS and BECS accessories into Class 
II devices with special controls and subject to premarket review. The 
proposed special controls for these devices are necessary to provide a 
reasonable assurance of safety and effectiveness. FDA has cleared 220 
BECS and BECS accessories under the 510(k) program consistent with the 
recommendations in the FDA guidance, ``Guidance for the Content of 
Premarket Submissions for Software Contained in Medical Devices,'' 
dated May 2005 (Ref. 4). As current practice, manufacturers already 
conform to the risk mitigations that are being proposed as special 
controls for BECS and BECS accessories, so this rule would essentially 
formalize current practice and will not result in any additional 
associated costs. Likewise, this classification will not result in any 
significant changes in how 510(k) premarket notifications for the 
affected devices are submitted or prepared by manufacturers or in how 
they are reviewed by FDA. Therefore, compliance with the special 
controls proposed for this device would not yield significant new costs 
for affected manufacturers. Because the classification of these devices 
to Class II (special controls) would not impose significant new 
obligations on manufacturers, the Agency concludes that the proposed 
rule, if finalized, will impose no additional regulatory burdens.

VII. Paperwork Reduction Act

    This proposed rule refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3520). The collections of information in 21 CFR part 807 subpart E 
have been approved under OMB control number 0910-0120, and the 
collections of information in 21 CFR subpart 801 have been approved 
under OMB control number 0910-0485. Therefore, FDA tentatively 
concludes that the proposed requirements in this document are not 
subject to review by OMB because they do not constitute a ``new 
collection of information'' under the PRA.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. Blood Product Advisory Committee Meeting transcript--March 20, 
1998 (http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3391t2.pdf).
2. Blood Product Advisory Committee Meeting transcript--December 3, 
2014 (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm386681.htm).
3. FDA Executive Summary. Blood Products Advisory Committee 
Meeting--December 3, 2014 (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm427392.htm).
4. Guidance for Industry and FDA Staff: Guidance for the Content of 
Premarket Submissions for Software Contained in Medical Devices, May 
2005, http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm089543.htm.

List of Subjects in 21 CFR Part 864

    Blood, Medical devices, Packaging and containers.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, FDA proposes 
to amend part 864 as follows:

[[Page 10557]]

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

0
1. The authority citation for 21 CFR part 864 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. In subpart J, add Sec.  864.9165 to read as follows:


Sec.  864.9165  Blood establishment computer software and accessories.

    (a) Identification. Blood establishment computer software (BECS) 
and BECS accessories are devices used in the manufacture of blood and 
blood components to assist in the prevention of disease in humans by 
identifying ineligible donors, by preventing the release of unsuitable 
blood and blood components for transfusion or for further manufacturing 
into products for human treatment or diagnosis, by performing 
compatibility testing between donor and recipient, or by performing 
positive identification of patients and blood components at the point 
of transfusion to prevent transfusion reactions. A BECS accessory is 
intended for use with BECS to augment its performance or to expand or 
modify its indications for use.
    (b) Classification--Class II (special controls). The special 
controls for these devices are:
    (1) Software performance and functional requirements including 
detailed design specifications (e.g., algorithms or control 
characteristics, alarms, device limitations, and safety requirements).
    (2) Verification and validation testing and hazard analysis must be 
performed.
    (3) Labeling must include:
    (i) Software limitations;
    (ii) Unresolved anomalies, annotated with an explanation of the 
impact on safety or effectiveness;
    (iii) Revision history; and
    (iv) Hardware and peripheral specifications.
    (4) Traceability matrix must be performed.
    (5) Performance testing to ensure the safety and effectiveness of 
the system must be performed, including when adding new functional 
requirements (e.g., electrical safety, electromagnetic compatibility, 
or wireless coexistence).

    Dated: February 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04411 Filed 2-29-16; 8:45 am]
BILLING CODE 4164-01-P



                                                                                Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Proposed Rules                                           10553

                                                      DEPARTMENT OF HEALTH AND                                 that if you include your name, contact                information as ‘‘confidential.’’ Any
                                                      HUMAN SERVICES                                           information, or other information that                information marked as ‘‘confidential’’
                                                                                                               identifies you in the body of your                    will not be disclosed except in
                                                      Food and Drug Administration                             comments, that information will be                    accordance with 21 CFR 10.20 and other
                                                                                                               posted on http://www.regulations.gov.                 applicable disclosure law. For more
                                                      21 CFR Part 864                                            • If you want to submit a comment                   information about FDA’s posting of
                                                                                                               with confidential information that you                comments to public dockets, see 80 FR
                                                      [Docket No. FDA–2016–N–0406]
                                                                                                               do not wish to be made available to the               56469, September 18, 2015, or access
                                                      Medical Devices; Hematology and                          public submit the comment as a written/               the information at: http://www.gpo.gov/
                                                      Pathology Devices; Classification of                     paper submission and in the manner                    fdsys/pkg/FR-2015-09-18/pdf/2015-
                                                      Blood Establishment Computer                             detailed (see ‘‘Written/Paper                         23389.pdf.
                                                      Software and Accessories                                 Submissions’’ and ‘‘Instructions’’).                     Docket: For access to the docket to
                                                                                                                                                                     read background documents or the
                                                                                                               Written/Paper Submissions
                                                      AGENCY:    Food and Drug Administration,                                                                       electronic and written/paper comments
                                                      HHS.                                                        Submit written/paper submissions as                received, go to http://
                                                      ACTION:   Proposed rule.                                 follows:                                              www.regulations.gov and insert the
                                                                                                                  • Mail/Hand delivery/Courier (for                  docket number, found in brackets in the
                                                      SUMMARY:    The Food and Drug                            written/paper submissions): Division of               heading of this document, into the
                                                      Administration (FDA, Agency, or we) is                   Dockets Management (HFA–305), Food                    ‘‘Search’’ box and follow the prompts
                                                      proposing to classify the blood                          and Drug Administration, 5630 Fishers                 and/or go to the Division of Dockets
                                                      establishment computer software                          Lane, Rm. 1061, Rockville, MD 20852.                  Management, 5630 Fishers Lane, Rm.
                                                      (BECS) and BECS accessories into class                      • For written/paper comments                       1061, Rockville, MD 20852.
                                                      II (special controls). FDA is identifying                submitted to the Division of Dockets
                                                                                                                                                                     FOR FURTHER INFORMATION CONTACT:
                                                      proposed special controls for BECS and                   Management, FDA will post your
                                                                                                                                                                     Jessica T. Walker, Center for Biologics
                                                      BECS accessories that are necessary to                   comment, as well as any attachments,
                                                                                                                                                                     Evaluation and Research, Food and
                                                      provide a reasonable assurance of safety                 except for information submitted,
                                                                                                                                                                     Drug Administration, 10903 New
                                                      and effectiveness. FDA is also giving                    marked and identified, as confidential,
                                                                                                                                                                     Hampshire Ave., Bldg. 71, Rm. 7301,
                                                      notice that the Agency does not intend                   if submitted as detailed in
                                                                                                                                                                     Silver Spring, MD 20993–0002, 240–
                                                      to exempt BECS and BECS accessories                      ‘‘Instructions.’’
                                                                                                                  Instructions: All submissions received             402–7911.
                                                      from premarket notification                                                                                    SUPPLEMENTARY INFORMATION:
                                                      requirements of the Federal Food, Drug,                  must include the Docket No. FDA–
                                                      and Cosmetic Act (the FD&C Act). FDA                     2016–N–0406 for ‘‘Medical Devices;                    I. Background
                                                      is publishing in this document the                       Hematology and Pathology Devices;
                                                                                                               Classification of Blood Establishment                 A. Statutory and Regulatory Authorities
                                                      recommendations of the Blood Product
                                                      Advisory Committee regarding the                         Computer Software and Accessories.’’                     The FD&C Act (21 U.S.C. 301 et seq.),
                                                      classification of these devices. After                   Received comments will be placed in                   as amended by the Medical Device
                                                      considering public comments on the                       the docket and, except for those                      Amendments of 1976, establishes a
                                                      proposed classification, FDA will                        submitted as ‘‘Confidential                           comprehensive system for the regulation
                                                      publish a final regulation classifying                   Submissions,’’ publicly viewable at                   of medical devices intended for human
                                                      these device types.                                      http://www.regulations.gov or at the                  use. Section 513 of the FD&C Act (21
                                                                                                               Division of Dockets Management                        U.S.C. 360c) establishes three categories
                                                      DATES: Submit either electronic or
                                                                                                               between 9 a.m. and 4 p.m., Monday                     (classes) of devices depending on the
                                                      written comments by May 31, 2016.                        through Friday.                                       regulatory controls needed to provide
                                                      Please see section IV of this document                      • Confidential Submissions—To                      reasonable assurance of their safety and
                                                      for the proposed effective date of a final               submit a comment with confidential                    effectiveness. The three categories of
                                                      rule that may issue based on this                        information that you do not wish to be                devices are class I (general controls),
                                                      proposal.                                                made publicly available submit your                   class II (special controls), and class III
                                                      ADDRESSES:       You may submit comments                 comments only as a written/paper                      (premarket approval).
                                                      as follows:                                              submission. You should submit two                        Class I devices are those devices for
                                                                                                               copies total. One copy will include the               which the general controls of the FD&C
                                                      Electronic Submissions                                   information you claim to be confidential              Act (controls authorized by or under
                                                        Submit electronic comments in the                      with a heading or cover note that states              sections 501, 502, 510, 516, 518, 519, or
                                                      following way:                                           ‘‘THIS DOCUMENT CONTAINS                              520 or any combination of such
                                                        • Federal eRulemaking Portal: http://                  CONFIDENTIAL INFORMATION.’’ The                       sections) are sufficient to provide
                                                      www.regulations.gov. Follow the                          Agency will review this copy, including               reasonable assurance of safety and
                                                      instructions for submitting comments.                    the claimed confidential information, in              effectiveness; or those devices for which
                                                      Comments submitted electronically,                       its consideration of comments. The                    insufficient information exists to
                                                      including attachments, to http://                        second copy, which will have the                      determine that general controls are
                                                      www.regulations.gov will be posted to                    claimed confidential information                      sufficient to provide reasonable
                                                      the docket unchanged. Because your                       redacted/blacked out, will be available               assurance of safety and effectiveness or
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      comment will be made public, you are                     for public viewing and posted on                      to establish special controls to provide
                                                      solely responsible for ensuring that your                http://www.regulations.gov. Submit                    such assurance, but because the devices
                                                      comment does not include any                             both copies to the Division of Dockets                are not purported or represented to be
                                                      confidential information that you or a                   Management. If you do not wish your                   for a use in supporting or sustaining
                                                      third party may not wish to be posted,                   name and contact information to be                    human life or for a use which is of
                                                      such as medical information, your or                     made publicly available, you can                      substantial importance in preventing
                                                      anyone else’s Social Security number, or                 provide this information on the cover                 impairment of human health, and do
                                                      confidential business information, such                  sheet and not in the body of your                     not present a potential unreasonable
                                                      as a manufacturing process. Please note                  comments and you must identify this                   risk of illness or injury, are to be


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                                                      10554                    Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Proposed Rules

                                                      regulated by general controls (section                  a predicate device that does not require              accessories. The Panel believed that
                                                      513(a)(1)(A) of the FD&C Act). Class II                 premarket approval.                                   BECS and BECS accessories presented a
                                                      devices are those devices for which                        The Agency determines whether new                  potential unreasonable risk of illness,
                                                      general controls by themselves are                      devices are substantially equivalent to               injury, or death, and that sufficient
                                                      insufficient to provide reasonable                      previously marketed devices by means                  information exists to establish special
                                                      assurance of safety and effectiveness,                  of premarket notification procedures in               controls for these devices.
                                                      but for which there is sufficient                       section 510(k) of the FD&C Act (21                    Consequently, the Panel recommended
                                                      information to establish special controls               U.S.C. 360(k)) and part 807 of the                    that these devices be classified into
                                                      to provide such assurance, including the                regulations (21 CFR part 807).                        class II (special controls) with premarket
                                                      issue of performance standards,                            A person may market a                              review. FDA is not aware of new
                                                      postmarket surveillance, patient                        preamendments device that has been                    information that has arisen since this
                                                      registries, development and                             classified into class III through                     Panel meeting that would provide a
                                                      dissemination of guidelines,                            premarket notification procedures                     basis for different recommendations or
                                                      recommendations, and other                              without submission of a premarket                     findings. The recommendations of the
                                                      appropriate actions the Agency deems                    approval application (PMA) until FDA                  Panel are summarized in Section II.
                                                      necessary to provide such assurance                     issues a final order under section 515(b)
                                                                                                              of the FD&C Act (21 U.S.C. 360e(b))                   II. Panel Recommendation
                                                      (section 513(a)(1)(B) of the FD&C Act).
                                                      Class III devices are those devices for                 requiring premarket approval.                            This section summarizes the Panel’s
                                                      which insufficient information exists to                                                                      deliberations on December 3, 2014.
                                                                                                              B. Regulatory History of the Devices
                                                      determine that general controls and                                                                           A. Identification
                                                                                                                 After the enactment of the 1976
                                                      special controls would provide a
                                                                                                              amendments, FDA began to identify and                    FDA proposed the following
                                                      reasonable assurance of safety and
                                                                                                              classify all preamendments devices in                 definition of BECS and BECS accessory
                                                      effectiveness, and are purported or
                                                                                                              accordance with section 513(b) of the                 to the Panel for their consideration:
                                                      represented for a use in supporting or                  FD&C Act.                                             BECS and BECS accessories are devices
                                                      sustaining human life or for a use which                   The first BECS 510(k) premarket                    used in the manufacture of blood and
                                                      is of substantial importance in                         notification was cleared by FDA on                    blood components to assist in the
                                                      preventing impairment of human                          August 26, 1996. Information Data                     prevention of disease in humans by
                                                      health, or present a potential                          Management, Inc., submitted premarket                 identifying unsuitable blood donors by:
                                                      unreasonable risk of illness or injury                  notifications for their Components &                  (1) Preventing the release of unsuitable
                                                      (section 513(a)(1)(C) of the FD&C Act).                 Distribution Information System and                   blood and blood components for
                                                         Under section 513(d)(1) of the FD&C                  Donor Management Information System.                  transfusion or for further manufacturing
                                                      Act, devices that were in commercial                    These devices were compared to                        into products for human treatment or
                                                      distribution before the enactment of the                systems marketed prior to the 1976                    diagnosis; (2) performing compatibility
                                                      Medical Device Amendments of 1976                       medical device amendments, including                  testing between donor and recipient;
                                                      (1976 amendments), May 28, 1976                         the Blood Inventory Management                        and (3) performing positive
                                                      (generally referred to as                               System by Computer Sciences                           identification of patients and blood
                                                      ‘‘preamendments devices’’), are                         Corporation and the Donor Deferral                    components. A BECS accessory expands
                                                      classified after FDA: (1) Receives a                    Registry developed by the American                    or modifies the function of the BECS
                                                      recommendation from a device                            National Red Cross. Between 1996 and                  and/or indications for use of the BECS
                                                      classification panel (an FDA advisory                   December 2015, FDA has cleared 220                    device. These devices are intended for
                                                      committee); (2) publishes the panel’s                   BECS and BECS accessories under the                   use with or capable of functioning with
                                                      recommendation for comment, along                       510(k) program.                                       BECS for the purpose of augmenting or
                                                      with a proposed regulation classifying                     In 1998, FDA sought                                supplementing the BECS performance.
                                                      the device; and (3) publishes a final                   recommendations from the Blood
                                                      regulation classifying the device.                      Product Advisory Committee (BPAC)                     B. Recommended Classification of the
                                                         FDA has classified most                              serving as a Device Classification Panel              Panel
                                                      preamendments devices under these                       on the classification of BECS. The                      The Panel recommended that BECS
                                                      procedures, relying upon valid scientific               Device Classification Panel                           and BECS accessories be classified into
                                                      evidence as described in section                        recommended regulating BECS as a                      class II (special controls) with premarket
                                                      513(a)(3) of the FD&C Act and 21 CFR                    class II device with premarket review                 review, and that FDA revise the
                                                      860.7(c), to determine that there is                    (Ref. 1). The classification of BECS was              proposed definition of a BECS
                                                      reasonable assurance of the safety and                  not finalized following the Device                    accessory. The consensus of the Panel
                                                      effectiveness of a device under its                     Classification Panel’s recommendation                 was that class II classification (special
                                                      conditions of use.                                      in 1998 because of competing priorities.              controls) and premarket review would
                                                         Devices that were not in commercial                     On December 3, 2014, the BPAC,                     provide reasonable assurance of safety
                                                      distribution before May 28, 1976                        serving as a Device Classification Panel              and effectiveness of these devices and
                                                      (generally referred to as                               (the Panel), again convened to discuss                that there is sufficient information to
                                                      ‘‘postamendments devices’’), are                        the classification of BECS and BECS                   establish special controls to provide
                                                      classified automatically by section                     accessories (Ref. 2). The Panel discussed             such assurance for BECS and BECS
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                                                      513(f) of the FD&C Act into class III                   the risks to health associated with BECS              accessories.
                                                      without any FDA rulemaking process.                     and BECS accessories, the classification                The Panel considered the following
                                                      Those devices remain in class III and                   of BECS and BECS accessories, and if                  valid scientific evidence to make their
                                                      require premarket approval, unless and                  classified as class II devices, the special           recommendations regarding the safety
                                                      until: (1) FDA classifies or reclassifies               controls that would be required for                   and effectiveness of the device under its
                                                      the device into class I or II or (2) FDA                these devices. The Panel agreed that                  conditions of use. Specifically, the
                                                      issues an order finding the device to be                general controls were not sufficient to               Panel considered the history of safety
                                                      substantially equivalent, in accordance                 provide a reasonable assurance of safety              and effectiveness of BECS and BECS
                                                      with section 513(i) of the FD&C Act, to                 and effectiveness of BECS and BECS                    accessories over many years of use in


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                                                                               Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Proposed Rules                                               10555

                                                      blood establishments; the results of an                 to identify donors as deferred. The                   functional requirements, (e.g., electrical
                                                      FDA review of the scientific literature;                recalls were classified as class II and               safety, electromagnetic compatibility, or
                                                      medical device reports (MDRs) of                        class III. A class II recall is a situation           wireless coexistence).
                                                      adverse events or malfunctions; device                  in which use of or exposure to a                        The Panel members generally agreed
                                                      recalls; and a summary of FDA’s                         violative product may cause temporary                 with the special controls proposed by
                                                      extensive inspectional and regulatory                   or medically reversible adverse health                FDA. One Panel member commented
                                                      experiences with BECS and BECS                          consequences or where the probability                 that requiring the performance of
                                                      accessories.                                            of serious adverse health consequences                verification and validation and hazard
                                                        The Panel also commented on the                       is remote. A class III recall is a situation          analysis is not sufficient without
                                                      proposed definition of BECS                             in which use of or exposure to a                      defining what type of testing is
                                                      accessories: ‘‘A BECS accessory expands                 violative product is not likely to cause              necessary, and expressed particular
                                                      or modifies the function of the BECS                    adverse health consequences. No recalls               concern regarding the acceptable level
                                                      and/or indications for use of the BECS                  were classified as class I, a situation in            of verification for BECS. Another
                                                      device.’’ These devices are intended for                which there is reasonable probability                 member asked whether many of the
                                                      use with or capable of functioning with                 that the use of or exposure to a violative            proposed special controls should be
                                                      BECS for the purpose of augmenting or                   product will cause serious adverse                    considered general controls for the
                                                      supplementing the BECS performance.                     health consequences or death.                         purposes of software manufacturing
                                                      The Panel recommended that FDA                             FDA presented the following risks to               considering the evolution of technology.
                                                      clarify which added functionalities                     health associated with BECS and BECS
                                                      would be considered a BECS accessory                    accessories: (1) Transfusion reaction or               TABLE 1—HEALTH RISKS AND MITIGA-
                                                      and, therefore, subject to regulations as               death from the inadvertent release and                  TION MEASURES FOR BECS AND
                                                      a class II device with special controls.                transfusion of incompatible blood or                    BECS ACCESSORIES
                                                                                                              blood components; (2) transfusion
                                                      C. Risks to Health and Special Controls
                                                                                                              injury from the transfusion of                           Identified risks to
                                                        As required by section 513(f)(1)(A) of                inaccurately labeled and/or stored blood                       health          Mitigation measures
                                                      the FD&C Act, FDA provided to the                       components; (3) transfusion injury or
                                                      Panel the following summary of valid                    death from the release of blood                       Transfusion reaction     Performance and
                                                      scientific evidence regarding the                       components from otherwise ineligible                    or death.                functional require-
                                                      benefits and risks of BECS and BECS                     donors (for example, the transmission of                                         ments.
                                                      accessories. In the 1990s, during                       infectious diseases from the inadvertent              Transmission of infec-   Performance and
                                                      establishment inspections, FDA                                                                                  tious disease.           testing.
                                                                                                              release of blood components that have
                                                      investigators observed numerous                                                                               Donor health risk from   Labeling.
                                                                                                              tested positive for transfusion-                        too frequent or in-
                                                      problems with BECS, including software                  transmitted disease agents); and (4)                    appropriate dona-
                                                      programs that posed significant risks to                donor injury from inappropriate or                      tion.
                                                      health, such as the potential for release               excessive donation of blood or blood
                                                      for transfusion of blood and blood                      components.                                           III. Proposed Classification and FDA’s
                                                      components found to be reactive when                       FDA also proposed the measures                     Findings
                                                      tested with assays for Human                            described in table 1 to mitigate the risks
                                                      Immunodeficiency Virus. During the                      to health associated with BECS and                       After considering the
                                                      inspections, FDA found that unsuitable                  BECS accessories. The Panel agreed that               recommendations of the Panel and the
                                                      blood and blood components had been                     the risks to health and mitigation                    valid scientific evidence, including the
                                                      released and distributed as a result of                 measures identified by FDA and                        published literature, MDRs, recall
                                                      improperly designed software.                           summarized in table 1 are applicable to               information, and FDA’s extensive
                                                        From 1996 to 2014, FDA received 201                   BECS and BECS accessories.                            inspection and regulatory experiences
                                                      MDRs for BECS and BECS accessories.                        FDA next presented the following                   with these device types (Ref. 3), FDA
                                                      The majority (86 percent) of the MDRs                   special controls for the Panel’s                      proposes to classify BECS and BECS
                                                      were for device malfunctions. In                        considerations: (1) Software                          accessories into class II (special
                                                      addition, one death and nine injuries                   performance and functional                            controls) with premarket review. FDA
                                                      were reported. The reported patient                     requirements are provided in the                      believes general controls by themselves
                                                      death was not attributed to the BECS.                   premarket submission including                        are insufficient to provide reasonable
                                                      The information provided in the reports                 detailed design specifications (e.g.,                 assurance of safety and effectiveness for
                                                      of the nine injuries was insufficient to                algorithms or control characteristics,                these devices and that there is sufficient
                                                      accurately identify the nature of the                   alarms, device limitations, and safety                information to establish special controls
                                                      injuries or the attribution to BECS. The                requirements); (2) verification and                   to provide such assurance. FDA believes
                                                      remaining reports included events                       validation testing and hazard analysis                that special controls, in addition to
                                                      classified in various categories such as                are to be performed and provided in the               general controls, would provide a
                                                      user error, operational problems, and                   premarket submission; (3) labeling                    reasonable assurance of the safety and
                                                      labeling.                                               includes software limitations,                        effectiveness of BECS and BECS
                                                        Similarly, from 2006 to 2013, BECS                    unresolved anomalies, annotated with                  accessories and would, therefore,
                                                      manufacturers initiated 56 voluntary                    an explanation of the impact on safety                mitigate the risk to patients of
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                                                      device recalls. The deviations included                 or effectiveness, revision history, and               transfusion reaction or death and
                                                      programming errors, inadequate design                   hardware and peripheral specifications;               transmission of infectious disease and
                                                      requirements, and incorrect                             (4) traceability matrix performed and                 risks to donors because of inappropriate
                                                      implementation of the design. The                       provided in the premarket submission;                 donations.
                                                      potential consequences of the BECS                      and (5) performance testing is                           The special controls proposed for
                                                      deviations included presenting donors                   performed and provided in the                         BECS and BECS accessories, specifically
                                                      with incorrect donor history                            premarket submission, as necessary to                 performance and functional
                                                      questionnaires, failing to save certain                 ensure the safety and effectiveness of                requirements, device verification and
                                                      test results in donor records, and failing              the system, and when adding new                       validation, hazards analysis,


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                                                      10556                    Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Proposed Rules

                                                      traceability, and performance testing,                  significant regulatory action as defined              VII. Paperwork Reduction Act
                                                      collectively ensure that the                            by Executive Order 12866.
                                                      manufacturer performs and documents                        The Regulatory Flexibility Act                       This proposed rule refers to
                                                      the activities necessary to decrease the                requires Agencies to analyze regulatory               previously approved collections of
                                                      risk of malfunction that could result in                options that would minimize any                       information that are subject to review by
                                                      the adverse events noted above. Further,                significant impact of a rule on small                 the Office of Management and Budget
                                                      appropriate labeling ensures that the                   entities. Because the proposed                        (OMB) under the Paperwork Reduction
                                                      user of the device is provided clear                    regulation is consistent with historical              Act of 1995 (PRA) (44 U.S.C. 3501–
                                                      instructions for use, including the                     regulatory oversight given to this type of            3520). The collections of information in
                                                      limitations of the device, to reduce the                device, we propose to certify that the                21 CFR part 807 subpart E have been
                                                      risk of user error that could result in the             proposed rule will not have a significant             approved under OMB control number
                                                      risks to health associated with these                   economic impact on a substantial                      0910–0120, and the collections of
                                                      devices.                                                number of small entities.                             information in 21 CFR subpart 801 have
                                                         FDA has amended the proposed                            The Unfunded Mandates Reform Act                   been approved under OMB control
                                                      definition of BECS accessories                          of 1995 (section 202(a)) requires us to               number 0910–0485. Therefore, FDA
                                                      consistent with the recommendation of                   prepare a written statement, which                    tentatively concludes that the proposed
                                                      the Panel and made other minor edits to                 includes an assessment of anticipated                 requirements in this document are not
                                                      the definition of BECS and the special                  costs and benefits, before proposing                  subject to review by OMB because they
                                                      controls presented to the Panel in the                  ‘‘any rule that includes any Federal                  do not constitute a ‘‘new collection of
                                                      proposed regulation.                                    mandate that may result in the                        information’’ under the PRA.
                                                         Section 510(m) of the FD&C Act                       expenditure by State, local, and tribal
                                                                                                                                                                    VIII. References
                                                      provides that a class II device may be                  governments, in the aggregate, or by the
                                                      exempted from the premarket                             private sector, of $100,000,000 or more                 The following references have been
                                                      notification requirements under section                 (adjusted annually for inflation) in any              placed on display in the Division of
                                                      510(k) of the FD&C Act, if the Agency                   one year.’’ The current threshold after               Dockets Management (see ADDRESSES)
                                                      determines that premarket notification                  adjustment for inflation is $144 million,             and may be seen by interested persons
                                                      is not necessary to assure the safety and               using the most current (2014) Implicit                between 9 a.m. and 4 p.m., Monday
                                                      effectiveness of the device. The Agency                 Price Deflator for the Gross Domestic                 through Friday; they are also available
                                                      does not intend to exempt BECS and                      Product. This proposed rule would not                 electronically at http://
                                                      BECS accessories from 510(k) premarket                  result in an expenditure in any year that             www.regulations.gov. FDA has verified
                                                      notification as allowed under section                   meets or exceeds this amount.                         the Web site addresses, as of the date
                                                      510(m) of the FD&C Act. FDA believes                       This rule proposes to classify BECS                this document publishes in the Federal
                                                      premarket notification is necessary for                 and BECS accessories into Class II                    Register, but Web sites are subject to
                                                      these devices to assure their safety and                devices with special controls and                     change over time.
                                                      effectiveness.                                          subject to premarket review. The
                                                                                                              proposed special controls for these                   1. Blood Product Advisory Committee
                                                      IV. Proposed Effective Date                             devices are necessary to provide a                         Meeting transcript—March 20, 1998
                                                                                                                                                                         (http://www.fda.gov/ohrms/dockets/ac/
                                                        FDA proposes that any final                           reasonable assurance of safety and                         98/transcpt/3391t2.pdf).
                                                      regulation based on this proposal                       effectiveness. FDA has cleared 220                    2. Blood Product Advisory Committee
                                                      become effective 30 days after its date                 BECS and BECS accessories under the                        Meeting transcript—December 3, 2014
                                                      of publication in the Federal Register.                 510(k) program consistent with the                         (http://www.fda.gov/
                                                                                                              recommendations in the FDA guidance,                       AdvisoryCommittees/
                                                      V. Environmental Impact                                 ‘‘Guidance for the Content of Premarket                    CommitteesMeetingMaterials/
                                                        We have determined under 21 CFR                       Submissions for Software Contained in                      BloodVaccinesandOtherBiologics/
                                                      25.34(b) that this action is of a type that             Medical Devices,’’ dated May 2005 (Ref.                    BloodProductsAdvisoryCommittee/
                                                      does not individually or cumulatively                   4). As current practice, manufacturers                     ucm386681.htm).
                                                                                                              already conform to the risk mitigations               3. FDA Executive Summary. Blood Products
                                                      have a significant effect on the human
                                                                                                                                                                         Advisory Committee Meeting—
                                                      environment. Therefore, neither an                      that are being proposed as special                         December 3, 2014 (http://www.fda.gov/
                                                      environmental assessment nor an                         controls for BECS and BECS accessories,                    AdvisoryCommittees/
                                                      environmental impact statement is                       so this rule would essentially formalize                   CommitteesMeetingMaterials/
                                                      required.                                               current practice and will not result in                    BloodVaccinesandOtherBiologics/
                                                                                                              any additional associated costs.                           BloodProductsAdvisoryCommittee/
                                                      VI. Analysis of Impacts                                 Likewise, this classification will not                     ucm427392.htm).
                                                        We have examined the impacts of the                   result in any significant changes in how              4. Guidance for Industry and FDA Staff:
                                                      proposed rule under Executive Order                     510(k) premarket notifications for the                     Guidance for the Content of Premarket
                                                      12866, Executive Order 13563, the                       affected devices are submitted or                          Submissions for Software Contained in
                                                      Regulatory Flexibility Act (5 U.S.C.                    prepared by manufacturers or in how                        Medical Devices, May 2005, http://
                                                                                                                                                                         www.fda.gov/medicaldevices/
                                                      601–612), and the Unfunded Mandates                     they are reviewed by FDA. Therefore,                       deviceregulationandguidance/
                                                      Reform Act of 1995 (Pub. L. 104–4).                     compliance with the special controls                       guidancedocuments/ucm089543.htm.
                                                      Executive Orders 12866 and 13563                        proposed for this device would not
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                                                      direct us to assess all costs and benefits              yield significant new costs for affected              List of Subjects in 21 CFR Part 864
                                                      of available regulatory alternatives and,               manufacturers. Because the
                                                                                                                                                                      Blood, Medical devices, Packaging
                                                      when regulation is necessary, to select                 classification of these devices to Class II
                                                                                                                                                                    and containers.
                                                      regulatory approaches that maximize                     (special controls) would not impose
                                                      net benefits (including potential                       significant new obligations on                          Therefore, under the Federal Food,
                                                      economic, environmental, public health                  manufacturers, the Agency concludes                   Drug, and Cosmetic Act and under
                                                      and safety, and other advantages;                       that the proposed rule, if finalized, will            authority delegated to the Commissioner
                                                      distributive impacts; and equity). We                   impose no additional regulatory                       of Food and Drugs, FDA proposes to
                                                      believe that this proposed rule is not a                burdens.                                              amend part 864 as follows:


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                                                                               Federal Register / Vol. 81, No. 40 / Tuesday, March 1, 2016 / Proposed Rules                                            10557

                                                      PART 864—HEMATOLOGY AND                                 DEPARTMENT OF HOMELAND                                I. Table of Abbreviations
                                                      PATHOLOGY DEVICES                                       SECURITY                                              CFR Code of Federal Regulations
                                                                                                                                                                    DHS Department of Homeland Security
                                                      ■ 1. The authority citation for 21 CFR                  Coast Guard
                                                                                                                                                                    FR Federal Register
                                                      part 864 continues to read as follows:                                                                        NPRM Notice of proposed rulemaking
                                                                                                              33 CFR Part 100                                       U.S.C. United States Code
                                                        Authority: 21 U.S.C. 351, 360, 360c, 360e,
                                                      360j, 371.                                              [Docket Number USCG–2016–0134]
                                                                                                                                                                    II. Background, Purpose, and Legal
                                                      ■ 2. In subpart J, add § 864.9165 to read               RIN 1625–AA08                                         Basis
                                                      as follows:
                                                                                                              Special Local Regulations; Fajardo                       On April 4, 2016, Puerto Rico
                                                      § 864.9165 Blood establishment computer                 Offshore Challenge; Rada Fajardo;                     Offshore Series, Inc. is sponsoring the
                                                      software and accessories.                               Fajardo, Puerto Rico                                  Fajardo Offshore Challenge, a series of
                                                         (a) Identification. Blood establishment                                                                    high-speed boat races. The races will be
                                                                                                              AGENCY:   Coast Guard, DHS.                           held on the waters of Rada Fajardo in
                                                      computer software (BECS) and BECS                       ACTION:   Notice of proposed rulemaking.
                                                      accessories are devices used in the                                                                           Fajardo, Puerto Rico. Approximately 30
                                                      manufacture of blood and blood                                                                                high-speed power boats and PWCs will
                                                                                                              SUMMARY:   The Coast Guard is proposing
                                                      components to assist in the prevention                                                                        be participating in the races.
                                                                                                              to establish a special local regulation on
                                                      of disease in humans by identifying                     the waters of Rada Fajardo in Fajardo,                   The purpose of this proposed
                                                      ineligible donors, by preventing the                    Puerto Rico during the Fajardo Offshore               rulemaking is to ensure the safety of
                                                      release of unsuitable blood and blood                   Challenge, a high speed boat race. The                vessels and the navigable waters within
                                                      components for transfusion or for                       event is scheduled to take place on                   the regulated areas before, during, and
                                                      further manufacturing into products for                 Sunday, April 4, 2016. Approximately                  after the scheduled event. The Coast
                                                      human treatment or diagnosis, by                        30 high-speed power boats will be                     Guard proposes this rulemaking under
                                                      performing compatibility testing                        participating in the races. The special               authority in 33 U.S.C. 1231.
                                                      between donor and recipient, or by                      local regulation is necessary for the                 III. Discussion of Proposed Rule
                                                      performing positive identification of                   safety of the race participants,
                                                      patients and blood components at the                    participant vessels, and the general                     The special local regulation
                                                      point of transfusion to prevent                         public during the event. The special                  encompass certain waters of Rada
                                                      transfusion reactions. A BECS accessory                 local regulation would establish the                  Fajardo in Fajardo, Puerto Rico. The
                                                      is intended for use with BECS to                        following two areas: one race area,                   proposed special local regulation would
                                                      augment its performance or to expand or                 where all persons and vessels, except                 be enforced from 10 a.m. until 4 p.m. on
                                                      modify its indications for use.                         those persons and vessels participating               April 4, 2016. The special local
                                                         (b) Classification—Class II (special                 in the high-speed boat races, are                     regulation consist of the following two
                                                      controls). The special controls for these               prohibited from entering, transiting                  areas: (1) A race area, where all persons
                                                      devices are:                                            through, anchoring in, or remaining                   and vessels, except those persons and
                                                         (1) Software performance and                         within; and a buffer zone around the                  vessels participating in the high-speed
                                                      functional requirements including                       race area, where all persons and vessels,             boat races, are prohibited from entering,
                                                      detailed design specifications (e.g.,                   except those persons and vessels                      transiting through, anchoring in, or
                                                      algorithms or control characteristics,                  enforcing the buffer zone, are prohibited             remaining within; and (2) a buffer zone
                                                      alarms, device limitations, and safety                  from entering, transiting through,                    around the race area, where all persons
                                                      requirements).                                          anchoring in, or remaining within                     and vessels, except those persons and
                                                                                                              unless authorized by the Captain of the               vessels enforcing the buffer zone, are
                                                         (2) Verification and validation testing              Port San Juan or a designated                         prohibited from entering, transiting
                                                      and hazard analysis must be performed.                  representative. We invite your                        through, anchoring in, or remaining
                                                         (3) Labeling must include:                           comments on this proposed rulemaking.                 within unless authorized by the Captain
                                                         (i) Software limitations;                            DATES: Comments and related material                  of the Port San Juan or a designated
                                                         (ii) Unresolved anomalies, annotated                 must be received by the Coast Guard on                representative. Persons and vessels may
                                                      with an explanation of the impact on                    or before March 21, 2016.                             request authorization to enter, transit
                                                      safety or effectiveness;                                ADDRESSES: You may submit comments                    through, anchor in, or remain within the
                                                                                                              identified by docket number USCG–                     race area or buffer zone by contacting
                                                         (iii) Revision history; and                                                                                the Captain of the Port San Juan by
                                                                                                              2016–0134 using the Federal
                                                         (iv) Hardware and peripheral                         eRulemaking Portal at http://                         telephone at (787) 289–2041, or a
                                                      specifications.                                         www.regulations.gov. See the ‘‘Public                 designated representative via VHF radio
                                                         (4) Traceability matrix must be                      Participation and Request for                         on channel 16. If authorization to enter,
                                                      performed.                                              Comments’’ portion of the                             transit through, anchor in, or remain
                                                         (5) Performance testing to ensure the                SUPPLEMENTARY INFORMATION section for                 within the race area or buffer zone is
                                                      safety and effectiveness of the system                  further instructions on submitting                    granted by the Captain of the Port San
                                                                                                              comments.                                             Juan or a designated representative, all
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS




                                                      must be performed, including when
                                                      adding new functional requirements                                                                            persons and vessels receiving such
                                                                                                              FOR FURTHER INFORMATION CONTACT:     If               authorization must comply with the
                                                      (e.g., electrical safety, electromagnetic               you have questions about this proposed
                                                      compatibility, or wireless coexistence).                                                                      instructions of the Captain of the Port
                                                                                                              rulemaking, call or email Mr. Efrain                  San Juan or a designated representative.
                                                        Dated: February 24, 2016.                             Lopez, Sector San Juan Prevention                     The Coast Guard will provide notice of
                                                      Leslie Kux,                                             Department, Coast Guard; telephone                    the special local regulation by Local
                                                      Associate Commissioner for Policy.                      (787) 289–2097, email efrain.lopez1@                  Notice to Mariners, Broadcast Notice to
                                                      [FR Doc. 2016–04411 Filed 2–29–16; 8:45 am]             uscg.mil.                                             Mariners, and on-scene designated
                                                      BILLING CODE 4164–01–P                                  SUPPLEMENTARY INFORMATION:                            representatives.


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Document Created: 2018-02-02 14:59:58
Document Modified: 2018-02-02 14:59:58
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesSubmit either electronic or written comments by May 31, 2016. Please see section IV of this document for the proposed effective date of a final rule that may issue based on this proposal.
ContactJessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FR Citation81 FR 10553 
CFR AssociatedBlood; Medical Devices and Packaging and Containers

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