82 FR 56763 - Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 229 (November 30, 2017)

Page Range		56763-56765
FR Document		2017-25781

The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain subtypes of surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA intends to limit the proposed exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. All other class II devices classified under FDA's surgical apparel classification regulation would continue to be subject to premarket notification requirements. FDA is publishing this document to obtain comments regarding this proposed exemption, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Federal Register, Volume 82 Issue 229 (Thursday, November 30, 2017)

[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Proposed Rules]
[Pages 56763-56765]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25781]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2017-N-4919]


Medical Devices; Exemption From Premarket Notification: Class II 
Devices; Surgical Apparel; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
its intention to exempt certain subtypes of surgical apparel from 
premarket notification requirements, subject to conditions and 
limitations. FDA intends to limit the proposed exemption to single-use, 
disposable respiratory protective devices (RPD) used in a healthcare 
setting and worn by healthcare personnel during procedures to protect 
both the patient and the healthcare personnel from the transfer of 
microorganisms, body fluids, and particulate material. These devices, 
commonly referred to as N95 filtering facepiece respirators (FFRs) and 
surgical N95 respirators (herein collectively referred to as N95s) are 
currently regulated by FDA under product code MSH. All other class II 
devices classified under FDA's surgical apparel classification 
regulation would continue to be subject to premarket notification 
requirements. FDA is publishing this document to obtain comments 
regarding this proposed exemption, in accordance with the Federal Food, 
Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments by January 29, 
2018.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way. Please note that 
late, untimely filed comments will not be considered. Electronic 
comments must be submitted on or before January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 29, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-N-4919 for ``Medical Devices; Exemption From Premarket 
Notification: Class II Devices; Surgical Apparel; Request for 
Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and

[[Page 56764]]

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: https://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 https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Aftin Ross, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5402, Silver Spring, MD 20993, 301-796-5679, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the 
implementing regulations, 21 CFR part 807 subpart E, require persons 
who intend to market a new device to submit and obtain clearance of a 
premarket notification (510(k)) containing information that allows FDA 
to determine whether the new device is ``substantially equivalent'' 
within the meaning of section 513(i) of the FD&C Act (21 U.S.C. 
360c(i)) to a legally marketed device that does not require premarket 
approval.
    The 21st Century Cures Act (Pub. L. 114-255) (Cures Act) was signed 
into law on December 13, 2016. Section 3054 of the Cures Act amended 
section 510(m) of the FD&C Act. As amended, section 510(m)(2) of the 
FD&C Act provides that, 1 calendar day after the date of publication of 
the final list under paragraph (1)(B), FDA may exempt a class II device 
from the requirement to submit a report under section 510(k) of the 
FD&C Act upon its own initiative or a petition of an interested person, 
if FDA determines that a report under section 510(k) is not necessary 
to assure the safety and effectiveness of the device. To do so, FDA 
must publish in the Federal Register notice of its intent to exempt the 
device, or of the petition, and provide a 60-calendar day period for 
public comment. Within 120 days after the issuance of the notice, FDA 
must publish an order in the Federal Register that sets forth its final 
determination regarding the exemption of the device that was the 
subject of the notice.

II. Factors FDA May Consider for Exemption

    There are a number of factors FDA may consider to determine whether 
a 510(k) is necessary to provide reasonable assurance of the safety and 
effectiveness of a class II device. These factors are discussed in the 
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently 
in the guidance the Agency issued on February 19, 1998, entitled 
``Procedures for Class II Device Exemptions From Premarket 
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k) 
Exemption Guidance'') (Ref. 1). Accordingly, FDA generally considers 
the following factors to determine whether a 510(k) is necessary for 
class II devices: (1) The device does not have a significant history of 
false or misleading claims or of risks associated with inherent 
characteristics of the device; (2) characteristics of the device 
necessary for its safe and effective performance are well established; 
(3) changes in the device that could affect safety and effectiveness 
will either (a) be readily detectable by users by visual examination or 
other means such as routine testing, before causing harm, or (b) not 
materially increase the risk of injury, incorrect diagnosis, or 
ineffective treatment; and (4) any changes to the device would not be 
likely to result in a change in the device's classification. FDA may 
also consider that, even when exempting devices, these devices would 
still be subject to the limitations on exemptions.

III. Proposed Class II Device Exemption

    FDA, on its own initiative, is proposing to exempt N95 filtering 
facepiece respirators (FFRs) and surgical N95 respirators (herein 
collectively referred to as N95s) from 510(k), subject to the 
conditions and limitations described in this section. FDA considers 
both of these devices to be a subset of ``surgical apparel'' intended 
to be worn by healthcare personnel to protect both the patient and the 
healthcare personnel from transfer of microorganisms, body fluids, and 
particulate material. As a result, these devices fall under the generic 
name ``surgical apparel'' and are classified in 21 CFR 878.4040(b)(1). 
In the Federal Register of June 24, 1988 (53 FR 23856), FDA issued a 
final rule classifying surgical apparel into class II (special 
controls). We are now announcing our intent to exempt a subset of 
surgical apparel devices currently regulated under product code MSH 
from 510(k) review. FDA has assessed the need for 510(k) against the 
criteria laid out in the Class II 510(k) Exemption Guidance and 
determined that these devices no longer require a 510(k) to provide 
reasonable assurance of safety and effectiveness. However, this 
exemption is limited and FDA's determination only applies to those N95s 
under the conditions listed below.
    FDA has a Memorandum of Understanding (MOU) with the Centers for 
Disease Control and Prevention (CDC), acting through its National 
Institute for Occupational Safety and Health (NIOSH) regarding 
oversight of N95s (Ref. 2). This agreement outlines the structure 
through which both Agencies will regulate N95s being proposed for 
exemption from 510(k). However, this MOU will not be effective unless 
and until, FDA publishes an order in the Federal Register, after 
reviewing comments, that sets forth its determination finalizing the 
510(k) exemption.
    Although FDA and CDC share a common public health mission, the 
Agencies have different statutory authorities and the distinct 
terminology could lead to confusion among stakeholders. In order to 
clearly identify the devices that are subject to this document, as well 
as the corresponding MOU, the following definitions are provided for 
the devices being proposed for exemption.
    The N95 FFR is a single-use disposable, half-mask respiratory 
protective device that covers the user's airway (nose and mouth) and 
offers protection from particulate materials at an N95 filtration 
efficiency level per 42 CFR 84.181. Such an N95 FFR used in a 
healthcare setting is a class II device, regulated by FDA under 21 CFR 
878.4040.
    The surgical N95 respirator is a single-use, disposable respiratory 
protective device used in a healthcare setting that is worn by HCP 
during procedures to protect both the patient and HCP from the transfer 
of microorganisms, body fluids, and particulate material at an N95 
filtration efficiency level per 42 CFR 84.181. The surgical N95 
respirator is also a class II device, regulated by FDA under 21 CFR 
878.4040.
    As described in the MOU, the following conditions must be met for 
N95s to be 510(k) exempt: (1) Application submitted to NIOSH is 
determined not to exceed the CDC and

[[Page 56765]]

FDA mutually agreed upon threshold evaluation criteria and (2) such 
applicants must have met approval criteria and have NIOSH approval. 
N95s with applications that meet the mutually agreed upon threshold 
evaluation criteria and approval criteria and remain approved by NIOSH 
would be exempt from FDA's 510(k) requirements under section 510(k) of 
the FD&C Act. Unless an N95 meets the mutually agreed upon threshold 
evaluation criteria and approval criteria and has NIOSH approval, the 
device would still be subject to 510(k) review; this includes devices 
with applications pending NIOSH review, as well as devices with no 
submitted applications.
    N95s are the only devices included within the scope of the MOU. As 
such, this proposed exemption would only apply to devices currently 
regulated by FDA under product code MSH. If finalized, this exemption 
would not affect any other subset of surgical apparel classified under 
21 CFR 878.4040. In addition to being subject to the general 
limitations to the exemptions found in 21 CFR 878.9 and the conditions 
of exemption identified in this document, these devices will also 
remain subject to current good manufacturing practices and other 
general controls under the statute. An exemption from the requirement 
of 510(k) does not mean that the device is exempt from any other 
statutory or regulatory requirements, unless such exemption is 
explicitly provided by order or regulation.

IV. 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; they are also 
available electronically at https://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. FDA Guidance, ``Procedures for Class II Device Exemptions from 
Premarket Notification, Guidance for Industry and CDRH Staff,'' 
February 19, 1998, available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.
2. ``Memorandum of Understanding Between the Food and Drug 
Administration, Center for Devices and Radiological Health, and the 
Centers for Disease Control and Prevention, National Institute for 
Occupational Safety and Health, National Personal Protective 
Technology Laboratory,'' available at https://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/.

List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321 et seq., as amended) and under authority delegated to the 
Commissioner of Food and Drugs, it is proposed that 21 CFR part 878 be 
amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for part 878 continues to read as follows:

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

0
2. In Sec.  878.4040, revise paragraph (b)(1) to read as follows:


Sec.  878.4040  Surgical apparel.

* * * * *
    (b) * * *
    (1) Class II (special controls) for surgical gowns and surgical 
masks. A surgical N95 respirator or N95 filtering facepiece respirator 
is not exempt if it is intended to prevent specific diseases or 
infections, or it is labeled or otherwise represented as filtering 
surgical smoke or plumes, filtering specific amounts of viruses or 
bacteria, reducing the amount of and/or killing viruses, bacteria, or 
fungi, or affecting allergenicity, or it contains coating technologies 
unrelated to filtration (e.g., to reduce and or kill microorganisms). 
Surgical N95 respirators and N95 filtering facepiece respirators are 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec.  878.9, and the following 
conditions for exemption:
    (i) The user contacting components of the device must be 
demonstrated to be biocompatible.
    (ii) Analysis and nonclinical testing must:
    (A) Characterize flammability and be demonstrated to be appropriate 
for the intended environment of use; and
    (B) Demonstrate the ability of the device to resist penetration by 
fluids, such as blood and body fluids, at a velocity consistent with 
the intended use of the device.
    (iii) NIOSH approved under its regulation.
* * * * *

    Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25781 Filed 11-29-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 229 / Thursday, November 30, 2017 / Proposed Rules 56765

FDA mutually agreed upon threshold https://www.fda.gov/AboutFDA/ DEPARTMENT OF THE TREASURY
evaluation criteria and (2) such PartnershipsCollaborations/
applicants must have met approval MemorandaofUnderstandingMOUs/ Internal Revenue Service
DomesticMOUs/.
criteria and have NIOSH approval. N95s
with applications that meet the 26 CFR Part 301
List of Subjects in 21 CFR Part 878
mutually agreed upon threshold [REG–119337–17]
evaluation criteria and approval criteria Medical devices.
and remain approved by NIOSH would Therefore, under the Federal Food, RIN 1545–BN95
be exempt from FDA’s 510(k) Drug, and Cosmetic Act (21 U.S.C. 321
requirements under section 510(k) of the Centralized Partnership Audit Regime:
et seq., as amended) and under International Tax Rules
FD&C Act. Unless an N95 meets the authority delegated to the Commissioner
mutually agreed upon threshold of Food and Drugs, it is proposed that AGENCY: Internal Revenue Service (IRS),
evaluation criteria and approval criteria 21 CFR part 878 be amended as follows: Treasury.
and has NIOSH approval, the device ACTION: Notice of proposed rulemaking.
would still be subject to 510(k) review; PART 878—GENERAL AND PLASTIC
this includes devices with applications SURGERY DEVICES SUMMARY: This document contains
pending NIOSH review, as well as proposed regulations implementing
devices with no submitted applications. ■ 1. The authority citation for part 878 section 1101 of the Bipartisan Budget
N95s are the only devices included continues to read as follows: Act of 2015 (BBA), which was enacted
within the scope of the MOU. As such, Authority: 21 U.S.C. 351, 360, 360c, 360e, into law on November 2, 2015. Section
this proposed exemption would only 360j, 360l, 371. 1101 of the BBA repeals the current
apply to devices currently regulated by ■ 2. In § 878.4040, revise paragraph rules governing partnership audits and
FDA under product code MSH. If (b)(1) to read as follows: replaces them with a new centralized
finalized, this exemption would not partnership audit regime that, in
affect any other subset of surgical § 878.4040 Surgical apparel. general, assesses and collects tax at the
apparel classified under 21 CFR * * * * * partnership level. These proposed
878.4040. In addition to being subject to (b) * * * regulations provide rules addressing
the general limitations to the (1) Class II (special controls) for how certain international rules operate
exemptions found in 21 CFR 878.9 and surgical gowns and surgical masks. A in the context of the centralized
the conditions of exemption identified surgical N95 respirator or N95 filtering partnership audit regime, including
in this document, these devices will facepiece respirator is not exempt if it rules relating to the withholding of tax
also remain subject to current good is intended to prevent specific diseases on foreign persons, withholding of tax
manufacturing practices and other or infections, or it is labeled or to enforce reporting on certain foreign
general controls under the statute. An otherwise represented as filtering accounts, and the treatment of
exemption from the requirement of surgical smoke or plumes, filtering creditable foreign tax expenditures of a
510(k) does not mean that the device is specific amounts of viruses or bacteria, partnership.
exempt from any other statutory or reducing the amount of and/or killing DATES: Written or electronic comments
regulatory requirements, unless such viruses, bacteria, or fungi, or affecting and requests for a public hearing must
exemption is explicitly provided by allergenicity, or it contains coating be received by January 29, 2018.
order or regulation. technologies unrelated to filtration (e.g., ADDRESSES: Send submissions to:
to reduce and or kill microorganisms). CC:PA:LPD:PR (REG–119337–17), Room
IV. References Surgical N95 respirators and N95 5207, Internal Revenue Service, P.O.
The following references are on filtering facepiece respirators are Box 7604, Ben Franklin Station,
display in the Dockets Management exempt from the premarket notification Washington, DC 20044. Submissions
Staff (see ADDRESSES) and are available procedures in subpart E of part 807 of may be hand delivered Monday through
for viewing by interested persons this chapter subject to § 878.9, and the Friday between the hours of 8:00 a.m.
between 9 a.m. and 4 p.m., Monday following conditions for exemption: and 4:00 p.m. to CC:PA:LPD:PR (REG–
through Friday; they are also available (i) The user contacting components of 119337–17), Courier’s Desk, Internal
electronically at https:// the device must be demonstrated to be Revenue Service, 1111 Constitution
www.regulations.gov. FDA has verified biocompatible. Avenue NW., Washington, DC 20224, or
the Web site addresses, as of the date (ii) Analysis and nonclinical testing
sent electronically via the Federal
this document publishes in the Federal must:
(A) Characterize flammability and be eRulemaking Portal at
Register, but Web sites are subject to www.regulations.gov (IRS REG–119337–
change over time. demonstrated to be appropriate for the
intended environment of use; and 17).
1. FDA Guidance, ‘‘Procedures for Class II FOR FURTHER INFORMATION CONTACT:
(B) Demonstrate the ability of the
Device Exemptions from Premarket Concerning the proposed regulations
Notification, Guidance for Industry and device to resist penetration by fluids,
CDRH Staff,’’ February 19, 1998, such as blood and body fluids, at a relating to creditable foreign tax
available at https://www.fda.gov/ velocity consistent with the intended expenditures, Larry R. Pounders, Jr., of
downloads/MedicalDevices/ use of the device. the Office of Associate Chief Counsel
DeviceRegulationandGuidance/ (iii) NIOSH approved under its (International), (202) 317–5465;
nshattuck on DSK9F9SC42PROD with PROPOSALS

GuidanceDocuments/UCM080199.pdf. regulation. concerning the proposed regulations
2. ‘‘Memorandum of Understanding Between relating to chapters 3 and 4 of subtitle
the Food and Drug Administration,
* * * * *
A of the Internal Revenue Code (other
Center for Devices and Radiological Dated: November 24, 2017. than section 1446), Subin Seth of the
Health, and the Centers for Disease Leslie Kux,
Control and Prevention, National Office of Associate Chief Counsel
Associate Commissioner for Policy. (International), (202) 317–5003;
Institute for Occupational Safety and
Health, National Personal Protective [FR Doc. 2017–25781 Filed 11–29–17; 8:45 am] concerning the proposed regulations
Technology Laboratory,’’ available at BILLING CODE 4164–01–P relating to section 1446, Ronald M.

VerDate Sep<11>2014 15:27 Nov 29, 2017 Jkt 244001 PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 E:\FR\FM\30NOP1.SGM 30NOP1

Document Created: 2017-11-30 00:35:04
Document Modified: 2017-11-30 00:35:04

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		Proposed Rules
Action		Proposed order; request for comments.
Dates		Submit either electronic or written comments by January 29, 2018.
Contact		Aftin Ross, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5402, Silver Spring, MD 20993, 301-796-5679, email: [email protected]
FR Citation		82 FR 56763

82 FR 56763 - Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 229 (November 30, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration