83 FR 23212 - 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 83, Issue 97 (May 18, 2018)

Page Range		23212-23218
FR Document		2018-10610

The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to classify blood establishment computer software (BECS) and BECS accessories (regulated under product code MMH) into class II (special controls). FDA has identified 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 (FD&C Act).

Federal Register, Volume 83 Issue 97 (Friday, May 18, 2018)

[Federal Register Volume 83, Number 97 (Friday, May 18, 2018)]
[Rules and Regulations]
[Pages 23212-23218]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-10610]

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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
issuing a final rule to classify blood establishment computer software
(BECS) and BECS accessories (regulated under product code MMH) into
class II (special controls). FDA has identified 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 (FD&C Act).

DATES: This rule is effective June 18, 2018.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jessica Walker Udechukwu, 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:

Table of Contents

I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Background
A. Need for the Regulation/History of This Rulemaking
B. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
A. Introduction
B. Specific Comments and FDA Response
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Final Rule

FDA is classifying BECS and BECS accessories into class II (special
controls). The Agency believes that the special controls established
and imposed by this final rule, together with the general controls,
will provide reasonable assurance of the safety and effectiveness of
these devices. In this final rule, FDA is also revising the definition
of BECS accessories from the definition in the proposed rule and
responding to comments received on the proposed rule. Lastly, FDA is
giving notice that the Agency does not intend to exempt BECS and BECS
accessories from the premarket notification requirements of the FD&C
Act.

B. Summary of the Major Provisions of the Final Rule

In this final rule, FDA is classifying BECS and BECS accessories
into class II (special controls). This rule creates Sec. 864.9165 in
21 CFR part 864, subpart J, to include the identification and
classification of BECS and BECS accessories. The classification of BECS
and BECS accessories is consistent with the FDA Blood Product Advisory
Committee (BPAC) recommendation that the devices be classified as class
II (special controls) devices with premarket review.

C. Legal Authority

We are issuing this final rule under section 513(a)(1)(B) of the
FD&C Act (21 U.S.C. 360c(a)(1)(B)). FDA has the authority under this
provision of the FD&C Act to issue a regulation to establish special
controls for class II

[[Page 23213]]

devices for which general controls by themselves are insufficient to
provide reasonable assurance of safety and effectiveness of the device,
and for which there is sufficient information to establish special
controls to provide such assurance. Under this authority, FDA is
establishing special controls for BECS and BECS accessories.

D. Costs and Benefits

FDA is finalizing this regulation to classify BECS and BES
accessories into class II (special controls). Because this final rule
would not impose significant new obligations on manufacturers, this
regulation is not anticipated to result in any significant new
compliance costs and the economic impact is expected to be minimal.

II. Background

The FD&C Act (21 U.S.C. 301 et seq.), as amended by the Medical
Device Amendments of 1976 (1976 Amendments), establishes a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act 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
of the device. Class I also includes 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 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
promulgation 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 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, along with a proposed regulation classifying
the device, and provides an opportunity for interested persons to
submit comments; 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.

A. Need for the Regulation/History of This Rulemaking

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. BECS and BECS accessories are preamendments
devices. 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 amendments, including
the Blood Inventory Management System by Computer Sciences Corp. and
the Donor Deferral Registry developed by the American National Red
Cross. Between 1996 and the time FDA drafted the proposed rule in
December 2015, FDA had cleared 220 BECS and BECS accessories under the
510(k) program. BECS and BECS accessories are regulated under product
code MMH.
In 1998, FDA sought recommendations from the 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.

[[Page 23214]]

Consequently, the Panel recommended that these devices be classified
into class II (special controls) with premarket review.
After considering the recommendations of the Panel and the valid
scientific evidence, including the published literature, medical device
reports, recall information, and FDA's extensive inspection and
regulatory experiences with these device types (Ref. 3), FDA published
a proposed rule in the Federal Register of March 1, 2016 (81 FR 10553),
to classify BECS and BECS accessories into class II (special controls)
with premarket review. In the proposed rule, FDA identified the risks
to health and the mitigation measures for BECS and BECS accessories.
FDA assessed the risks to health for BECS accessories and found these
risks to be the same as BECS and, therefore, proposed to classify the
BECS as the parent device and BECS accessories together. FDA is not
aware of any new information that has arisen since this Panel meeting
and the publication of the proposed rule that would provide a basis for
different recommendations or findings. 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 risks as
summarized in table 1.

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.
------------------------------------------------------------------------

The special controls that were proposed for BECS and BECS
accessories--specifically performance and functional requirements,
device verification and validation, hazard analysis, traceability
matrix, performance testing, and labeling--collectively ensure that the
manufacturer performs and documents the activities necessary to
decrease the risk of malfunction that could result in adverse events.
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.
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.

B. Summary of Comments to the Proposed Rule

Most of the comments expressed support for the proposed rule and
agreed with the proposed classification of BECS and BECS accessories as
class II devices and the proposed special controls. Two commenters
disagreed with the proposed classification of BECS and BECS accessories
into class II. Several comments requested clarification of the
definition of BECS accessory. Several commenters requested
clarification on the proposed special controls.

III. Legal Authority

We are issuing this final rule under section 513(a)(1)(B) of the
FD&C Act. FDA has the authority under this provision of the FD&C Act to
issue a regulation to establish special controls for class II devices
for which general controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide such
assurance. Under this authority, FDA is establishing special controls
for the class II devices for BECS and BECS accessories.

IV. Comments on the Proposed Rule and FDA Response

A. Introduction

In response to the proposed rule (81 FR 10553) to classify BECS and
BECS accessories into class II, we received seven comment letters by
the close of the comment period, each containing one or more comments
on one or more issues. We received comments from a blood establishment,
two trade organizations representing the blood and plasma industries,
one device manufacturer, one anonymous response, one private citizen,
and one public health research organization.
We describe and respond to the comments in section IV.B. We have
numbered each comment to help distinguish between different comments.
We have grouped similar comments together under the same number, and,
in some cases, we have separated different issues discussed in the same
comment and designated them as distinct comments for purposes of our
responses. The number assigned to each comment or comment topic is
purely for organizational purposes and does not signify the comment's
value or importance or the order in which comments were received.

B. Specific Comments and FDA Response

(Comment 1) One comment suggested that FDA has failed to establish
that BECS and BECS accessories present an ``unreasonable'' risk of
illness or injury.
(Response 1) We disagree. As presented to the Panel on December 3,
2014, in the 1990s during establishment inspection observations, it was
revealed that unsuitable blood and blood components had been released
and distributed as a result of improperly designed software. This posed
potential unreasonable risks to health such as transfusion reaction,
injury or death, and transmission of infectious disease. These
observations resulted in warning letters and recalls of the unsuitable
blood and blood components, as well as warning letters and recalls of
the defective software. Furthermore, as BECS programs became
increasingly complex, FDA investigators found that validation solely by
the end user of the device was proving impractical, and was
insufficient to assure software performance. Therefore, FDA determined
that there were potential unreasonable risks to health associated with
BECS and convened the Panel in December 2014. The Panel considered the
scientific evidence presented at the meeting and recommended that BECS
and BECS accessories be classified into

[[Page 23215]]

class II (special controls) with premarket review. After considering
the recommendations of the Panel and the valid scientific evidence,
including the published literature, medical device reports, recall
information, and FDA's extensive inspection and regulatory experiences
with these device types (Ref. 3), FDA proposed that BECS and BECS
accessories be classified into class II (special controls) with
premarket review. In the proposed rule, FDA proposed 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 risks to patients of transfusion
reaction or death and transmission of infectious disease and risks to
donors because of inappropriate donations. FDA is not aware of any new
information that has arisen since this Panel meeting and the
publication of the proposed rule that would provide a basis for
different recommendations or findings. Accordingly, this final rule
classifies BECS and BECS accessories into class II (special controls)
with premarket review.
(Comment 2) One comment recommended that the rule should detail the
requirements for verification and validation.
(Response 2) The final rule includes verification and validation
testing as a special control. FDA issued the guidance entitled
``General Principles of Software Validation; Final Guidance for
Industry and FDA Staff'' on January 11, 2002, which outlines general
validation principles and recommendations that are considered
applicable to the validation of medical device software, or the
validation of software used to design, develop, or manufacture medical
devices (Ref. 4). BECS manufacturers can follow the recommendations in
this guidance to help ensure appropriate validation testing of their
device. FDA believes that the recommendations in this guidance support
the requirements in the Quality System Regulation (21 CFR part 820),
and can assist manufacturers in meeting the requirements for
verification and validation testing as a special control.
(Comment 3) Multiple comments requested clarification of the
definition of BECS accessories.
(Response 3) FDA agrees that clarification of BECS accessories is
needed. To provide greater clarity we have revised the identification
language in the classification regulation. Under the final rule, a BECS
accessory is defined as a device intended for use with BECS to augment
its performance or to expand or modify its indications for use. In
response to comments, we are providing examples of BECS accessories.
The following examples are BECS accessories:
A software device that queries a BECS to find blood
components and donors that meet specific requirements, e.g., Human
Leukocyte Antigen and Cytomegalovirus status and allows the selections
of the most suitable blood component for the recipient and, in doing
so, expands the indications for use of the BECS.
A software device that augments the performance and
expands the indications for use of the BECS by providing biometric
technology to identify a blood donor.
A software device that augments the performance of the
BECS by providing algorithms for donor or transfusion management.
The following examples are not BECS accessories:
An interface that merely transmits data from an external
device to the BECS such as billing information or inventory information
to stock units in the blood bank is not a BECS accessory. These
functionalities are not related to the indications for use of a BECS
and do not alter the data of the BECS; thus, such an interface would
not meet the definition of a BECS accessory.
An interface from a blood pressure device to the BECS that
performs a straight transfer of blood pressure information but does not
modify the medical data before or during the transfer is not a BECS
accessory. The data transfer itself does not expand the indications for
use of the BECS; it merely transfers data without manipulation of the
data or addition of logic function. Thus, it would not meet the
definition of a BECS accessory.
An interface between two BECS systems that is a straight
transfer of information and where the interface software does not
modify the medical data before or during the transfer does not meet the
definition of a BECS accessory because it is not used to augment the
performance of the BECS or to expand or modify its indications for use.
An interface that merely transfers data from the BECS to
another device simply for donor appointments is not a BECS accessory.
It does not meet the definition of a BECS accessory because it is not
used to augment the performance of the BECS or to expand or modify its
indications for use (it is simply transferring data from the BECS).
(Comment 4) One comment recommended that we distinguish a BECS
accessory from Medical Device Data Systems (MDDS).
(Response 4) A BECS accessory is a device used with BECS to augment
the performance or expand or modify the indications for use of the
BECS. Like BECS, BECS accessories are not MDDS because they are
intended to do more than simply transfer, store, or display medical
device data or convert medical device data from one format to another
format in accordance with a preset specification.
Section 3060 of the 21st Century Cures Act (Cures Act), Pub. L.
114-255 (2016), amended the FD&C Act to add section 520(o) (21 U.S.C.
360j(o)), which describes certain software functions, including
functions performed by MDDS, that are excluded from the definition of
device in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). Section
3060 of the Cures Act further states that section 520(o) of the FD&C
Act shall not be construed to limit FDA's authority to regulate
software used in the manufacture and transfusion of blood and blood
components to assist in the prevention of disease in humans. Therefore,
BECS and BECS accessories are not covered by section 520(o)(1)(D) of
the FD&C Act, and FDA regulates BECS and BECS accessories as devices.
(Comment 5) One comment asked if software intended for the
maintenance of data that blood establishments use in making decisions
regarding the suitability of donors and the release of blood components
for transfusion or further manufacture would be classified as BECS.
(Response 5) Software that uses the stored data for the purposes of
identifying ineligible donors, preventing the release of unsuitable
blood and blood components for transfusion or for further manufacture,
performing compatibility testing between donor and recipient, or
performing positive identification of patients and blood components at
the point of transfusion would meet the definition of BECS. Software
intended for electronic storage of medical data without interpreting or
analyzing the data or altering the functions or parameters of any
connected medical device would not meet the definition of BECS.
(Comment 6) One comment stated that the definition of BECS does not
cover middleware applications used to send data from a device used in
blood collection centers to a Donor Management System and asked for
clarification regarding the regulation of such products.
(Response 6) Middleware applications that only transfer medical
data from one medical device to another medical

[[Page 23216]]

device and do not augment the performance or expand or modify the
indications for use of the BECS would not meet the definition of a BECS
accessory.
(Comment 7) One comment questioned whether beta testing should be
included as a special control.
(Response 7) The final regulation includes verification and
validation testing as a special control. Verification and validation
testing should include beta testing which can be performed in a user
environment or simulated user environment.
The guidance document entitled ``General Principles of Software
Validation; Final Guidance for Industry and FDA Staff'' issued January
11, 2002 (Ref. 4), provides recommendations on software validation.
(Comment 8) One comment asked FDA to clarify its expectations with
respect to the development and presentation of a traceability matrix.
(Comment 8) FDA has provided recommendations for developing a
traceability matrix in the document entitled, ``Guidance for Industry
and FDA Staff: Guidance for the Content of Premarket Submissions for
Software Contained in Medical Devices,'' issued May 11, 2005 (Ref. 5).
(Comment 9) One comment recommended we review BECS and BECS
accessories through the PMA (class III) approval process since there
have been injuries and deaths associated with these devices. The
comment also stated that there is not sufficient information to
establish class II special controls for the devices.
(Response 9) Although BECS and BECS accessories are currently
unclassified, FDA has regulated these devices for more than 20 years,
and during this time period, FDA has applied standards for class II
devices in reviewing 510(k)s for these devices. No deaths or serious
injuries have been attributed to the malfunction of the device. As
described in FDA's Executive Summary to the BPAC meeting of December 3,
2014 (Ref. 3), valid scientific evidence, including the published
literature, medical device reports, recall information, and FDA's
extensive inspection and regulatory experiences with these device
types, supports classifying BECS and BECS accessories into Class II
with special controls. After considering this evidence, the Panel
recommended classification of BECS and BECS accessories as a Class II
device with special controls. After considering the recommendations of
the Panel and the valid scientific evidence, FDA proposed that BECS and
BECS accessories be classified into class II (special controls) with
premarket review. In the proposed rule, FDA proposed 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 risks to patients of transfusion
reaction or death and transmission of infectious disease and risks to
donors because of inappropriate donations. FDA is not aware of any new
information that has arisen since this Panel meeting and the
publication of the proposed rule that would provide a basis for
different recommendations or findings. Accordingly, this final rule
classifies BECS and BECS accessories into class II (special controls)
with premarket review. For additional information on premarket
submissions, please refer to the following guidance documents:
``Guidance for Industry and FDA Staff: Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices,''
issued May 11, 2005 (Ref. 5), and ``Deciding When to Submit a 510(k)
for a Software Change to an Existing Device: Guidance for Industry and
FDA Staff,'' issued October 25, 2017 (Ref. 6).
(Comment 10) One comment stated that the proposed rule lacked a
cost/benefit discussion on the proposed classification.
(Response 10) Sections I.D. and VI. of this rule discusses FDA's
economic analysis of impacts of the final rule. As discussed in the
proposed rule and in sections I.D. and VI. of this final rule, under
current practice, manufacturers already conform to the special controls
for BECS and BECS accessories. This rule would essentially formalize
current practice, and will not result in any additional associated
costs or benefits.
(Comment 11) One comment stated that the Center for Devices and
Radiological Health in FDA has identified Sanguin Medusa 2000 with the
product code MMH; and it is listed as being cleared September 29, 1994,
which predates the first FDA cleared 510(k) for BECS identified in the
proposed rule.
(Response 11) While this comment is outside the scope of the
proposed rule, we appreciate the comment and will ensure that proper
product codes are assigned to this product, which is not a BECS or BECS
accessory.

V. Effective Date

This final rule will become effective 30 days after its publication
in the Federal Register.

VI. Economic Analysis of Impacts

We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, 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). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this rule is consistent with historical regulatory
oversight given to this type of device, and would not impose any
additional regulatory burdens, we certify that the final 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 issuing ``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 $148
million, using the most current (2016) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
This rule classifies BECS and BECS accessories into class II
devices with special controls and subject to premarket review. The
special controls for these devices are necessary to provide a
reasonable assurance of safety and effectiveness. Between 1996 and the
time that FDA drafted the proposed rule in December 2015, FDA had
cleared 220 BECS and BECS accessories under the 510(k) program,
consistent with the recommendations in the FDA guidance, ``Guidance for
Industry and FDA Staff;

[[Page 23217]]

Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices,'' issued May 11, 2005 (Ref. 5). As
current practice, manufacturers already conform to the recommended
controls for BECS and BECS accessories. 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 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 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 rule will impose no
additional regulatory burdens.

VII. Analysis of 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.

VIII. Paperwork Reduction Act of 1995

This final 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 part 801 have been approved under
OMB control number 0910-0485.

IX. Federalism

We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we conclude that the rule
does not contain policies that have federalism implications as defined
in the Executive Order and, consequently, a federalism summary impact
statement is not required.

X. Consultation and Coordination With Indian Tribal Governments

We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.

XI. References

The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. Blood Products Advisory Committee Meeting transcript, March 20,
1998 (http://www.fda.gov/ohrms/dockets/ac/98/transcpt/3391t2.pdf).
2. Blood Products Advisory Committee Meeting transcript, December 3,
2014 (https://wayback.archive-it.org/7993/20170111180042/http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm386681.htm).
3. FDA Executive Summary. Blood Products Advisory Committee Meeting,
December 3, 2014 (https://wayback.archive-it.org/7993/20170111180042/ http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/ucm386681.htm).
4. General Principles of Software Validation; Final Guidance for
Industry and FDA Staff, January 11, 2002 (https://www.fda.gov/downloads/MedicalDevices/.../ucm085371.pdf).
5. Guidance for Industry and FDA Staff: Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices, May
11, 2005 (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm089593.pdf).
6. Deciding When to Submit a 510(k) for a Software Change to an
Existing Device: Guidance for Industry and FDA Staff, October 25,
2017 (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm514737.pdf).

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, 21 CFR part
864 is amended as follows:

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

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

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

0
2. Add Sec. 864.9165 to subpart J to read as follows:

Sec. 864.9165 Blood establishment computer software and accessories.

(a) Identification. Blood establishment computer software (BECS) is
a device 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. This generic type of device may include a BECS
accessory, a device intended for use with BECS to augment the
performance of the BECS 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).

[[Page 23218]]

Dated: May 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10610 Filed 5-17-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 97 / Friday, May 18, 2018 / Rules and Regulations 23213

devices for which general controls by postmarket surveillance, patient A person may market a
themselves are insufficient to provide registries, development and preamendments device that has been
reasonable assurance of safety and dissemination of guidelines, classified into class III through
effectiveness of the device, and for recommendations, and other premarket notification procedures
which there is sufficient information to appropriate actions the Agency deems without submission of a premarket
establish special controls to provide necessary to provide such assurance approval application (PMA) until FDA
such assurance. Under this authority, (section 513(a)(1)(B) of the FD&C Act). issues a final order under section 515(b)
FDA is establishing special controls for Class III devices are those devices for of the FD&C Act (21 U.S.C. 360e(b))
BECS and BECS accessories. which insufficient information exists to requiring premarket approval.
D. Costs and Benefits determine that general controls and A. Need for the Regulation/History of
special controls would provide a This Rulemaking
FDA is finalizing this regulation to reasonable assurance of safety and
classify BECS and BES accessories into effectiveness, and are purported or After the enactment of the 1976
class II (special controls). Because this represented for a use in supporting or amendments, FDA began to identify and
final rule would not impose significant sustaining human life or for a use which classify all preamendments devices in
new obligations on manufacturers, this is of substantial importance in accordance with section 513(b) of the
regulation is not anticipated to result in preventing impairment of human FD&C Act. BECS and BECS accessories
any significant new compliance costs health, or present a potential are preamendments devices. The first
and the economic impact is expected to unreasonable risk of illness or injury BECS 510(k) premarket notification was
be minimal. (section 513(a)(1)(C) of the FD&C Act). cleared by FDA on August 26, 1996.
Under section 513(d)(1) of the FD&C Information Data Management, Inc.,
II. Background
Act, devices that were in commercial submitted premarket notifications for
The FD&C Act (21 U.S.C. 301 et seq.), their Components & Distribution
as amended by the Medical Device distribution before the enactment of the
Information System and Donor
Amendments of 1976 (1976 1976 amendments, May 28, 1976
Management Information System. These
Amendments), establishes a (generally referred to as
devices were compared to systems
comprehensive system for the regulation ‘‘preamendments devices’’), are
marketed prior to the 1976 amendments,
of medical devices intended for human classified after FDA: (1) Receives a
including the Blood Inventory
use. Section 513 of the FD&C Act recommendation from a device
Management System by Computer
establishes three categories (classes) of classification panel (an FDA advisory
Sciences Corp. and the Donor Deferral
devices depending on the regulatory committee); (2) publishes the panel’s
Registry developed by the American
controls needed to provide reasonable recommendation, along with a proposed
National Red Cross. Between 1996 and
assurance of their safety and regulation classifying the device, and
the time FDA drafted the proposed rule
effectiveness. The three categories of provides an opportunity for interested in December 2015, FDA had cleared 220
devices are class I (general controls), persons to submit comments; and (3) BECS and BECS accessories under the
class II (special controls), and class III publishes a final regulation classifying 510(k) program. BECS and BECS
(premarket approval). the device. accessories are regulated under product
Class I devices are those devices for FDA has classified most code MMH.
which the general controls of the FD&C preamendments devices under these In 1998, FDA sought
Act (controls authorized by or under procedures, relying upon valid scientific recommendations from the BPAC,
sections 501, 502, 510, 516, 518, 519, or evidence as described in section serving as a Device Classification Panel,
520 or any combination of such 513(a)(3) of the FD&C Act and 21 CFR on the classification of BECS. The
sections) are sufficient to provide 860.7(c), to determine that there is Device Classification Panel
reasonable assurance of safety and reasonable assurance of the safety and recommended regulating BECS as a
effectiveness of the device. Class I also effectiveness of a device under its class II device with premarket review
includes those devices for which conditions of use. (Ref. 1). The classification of BECS was
insufficient information exists to Devices that were not in commercial not finalized following the Device
determine that general controls are distribution before May 28, 1976 Classification Panel’s recommendation
sufficient to provide reasonable (generally referred to as in 1998 because of competing priorities.
assurance of safety and effectiveness or ‘‘postamendments devices’’), are On December 3, 2014, the BPAC,
to establish special controls to provide classified automatically by section serving as a Device Classification Panel
such assurance, but because the devices 513(f) of the FD&C Act into class III (the Panel), again convened to discuss
are not purported or represented to be without any FDA rulemaking process. the classification of BECS and BECS
for a use in supporting or sustaining Those devices remain in class III and accessories (Ref. 2). The Panel discussed
human life or for a use which is of require premarket approval, unless and the risks to health associated with BECS
substantial importance in preventing until: (1) FDA classifies or reclassifies and BECS accessories, the classification
impairment of human health, and do the device into class I or II or (2) FDA of BECS and BECS accessories, and, if
not present a potential unreasonable issues an order finding the device to be classified as class II devices, the special
risk of illness or injury, are to be substantially equivalent, in accordance controls that would be required for
regulated by general controls (section with section 513(i) of the FD&C Act, to these devices. The Panel agreed that
513(a)(1)(A) of the FD&C Act). Class II a predicate device that does not require general controls were not sufficient to
devices are those devices for which premarket approval. provide a reasonable assurance of safety
sradovich on DSK3GMQ082PROD with RULES

general controls by themselves are The Agency determines whether new and effectiveness of BECS and BECS
insufficient to provide reasonable devices are substantially equivalent to accessories. The Panel believed that
assurance of safety and effectiveness, previously marketed devices by means BECS and BECS accessories presented a
but for which there is sufficient of premarket notification procedures in potential unreasonable risk of illness,
information to establish special controls section 510(k) of the FD&C Act (21 injury, or death, and that sufficient
to provide such assurance, including the U.S.C. 360(k)) and part 807 of the information exists to establish special
promulgation of performance standards, regulations (21 CFR part 807). controls for these devices.

VerDate Sep<11>2014 15:59 May 17, 2018 Jkt 244001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\18MYR1.SGM 18MYR1

Document Created: 2018-05-18 02:15:33
Document Modified: 2018-05-18 02:15:33

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This rule is effective June 18, 2018.
Contact		Jessica Walker Udechukwu, 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 Citation		83 FR 23212
CFR Associated		Blood; Medical Devices and Packaging and Containers

83 FR 23212 - Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 97 (May 18, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration