83_FR_22942 83 FR 22846 - Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel

83 FR 22846 - Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 96 (May 17, 2018)

Page Range22846-22848
FR Document2018-10563

The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the 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. This exemption will decrease regulatory burden on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. All other class II devices classified under FDA's surgical apparel classification regulation continue to be subject to premarket notification requirements. FDA is also amending the codified language for the surgical apparel devices classification regulation to reflect this final determination.

Federal Register, Volume 83 Issue 96 (Thursday, May 17, 2018)
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Rules and Regulations]
[Pages 22846-22848]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10563]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing 
this final order to exempt certain surgical apparel from premarket 
notification requirements, subject to conditions and limitations. FDA 
is limiting the 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. This exemption will decrease 
regulatory burden on the medical device industry and will eliminate 
private costs and expenditures required to comply with certain Federal 
regulations. All other class II devices classified under FDA's surgical 
apparel classification regulation continue to be subject to premarket 
notification requirements. FDA is also amending the codified language 
for the surgical apparel devices classification regulation to reflect 
this final determination.

DATES: This order is effective May 17, 2018.

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 Federal Food, Drug, and Cosmetic Act (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 
shall 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)

[[Page 22847]]

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. Device Description

    FDA, upon its own initiative, is exempting 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 N95s 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 Sec.  878.4040(b)(1) (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 exempting 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 exempt from 510(k). The 
MOU between NIOSH and FDA is now effective as part of this final order.
    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 that are now exempt.
    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 Sec.  
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 Sec.  
878.4040.
    In the Federal Register of November 30, 2017 (82 FR 56763), FDA 
published a proposed order announcing its intent to exempt N95s from 
premarket notification [510(k)] requirements, subject to certain 
conditions and limitations, and provided opportunity for interested 
persons to submit comments by January 30, 2018. After reviewing the 
comments received (summarized in section IV), FDA is now providing its 
final determination for N95s by exempting this type of device from 
510(k) requirements, subject to certain conditions and limitations as 
identified in this final order. FDA is also amending the codified 
language for the surgical apparel devices classification regulation to 
reflect this final determination. Persons with pending 510(k) 
submissions for devices that are now exempt from 510(k), subject to the 
conditions and limitations, should withdraw their submissions.

IV. Comments on the Proposed Exemption and FDA's Response

    In response to the November 2017 proposed order announcing FDA's 
intent to exempt N95s from 510(k) requirements, FDA received 
submissions from four commenters--two from regulated industry, one from 
an industry association, and one from a consumer. Three commenters 
supported the implementation of the MOU with the CDC, acting through 
NIOSH, regarding oversight of N95s and exemption from 510(k) for this 
device type. FDA agrees with the three commenters that the exemption 
from 510(k) requirements will streamline the oversight of N95s without 
compromising the public health.
    One commenter requested that these devices still be subject to 
510(k) requirements to ensure safety of people using the disposable 
respiratory protective devices. Further, the commenter indicated that 
FDA's proposal should not be finalized because the sterility of these 
devices can greatly affect those working in the health field and 
patients being treated, and if these devices are not properly inspected 
or regulated, diseases could spread more easily from person to person. 
The commenter noted that because these devices will be used by surgical 
staff, it is even more important that the devices be inspected because 
surgery can involve open wounds or open body cavities, making it easier 
to spread disease or bodily fluids.
    FDA notes in response to this commenter that N95s subject to this 
exemption from 510(k) are not provided sterile to the user. While FDA 
has exempted these devices from 510(k), the scientific evidence 
necessary to legally market N95s within this exemption has not changed. 
The majority of this testing has traditionally been reviewed by NIOSH. 
The conditions and limitations of exemption that FDA has identified in 
section V of this final order and Sec.  878.4040(b)(1) will provide 
reasonable assurance of safety and effectiveness for N95s. 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. Accordingly, FDA did not modify the exemption 
or conditions and limitations of exemption proposed for N95s in 
response to this comment.

V. Conditions and Limitations of Exemption

    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's and FDA's 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 are exempt from FDA's 
510(k) requirements. Unless an N95 meets the mutually agreed upon 
threshold evaluation criteria and approval criteria and has NIOSH 
approval, the device is subject to 510(k) review; this includes devices 
with applications pending NIOSH review, as well as devices with no 
submitted applications. The threshold evaluation criteria are

[[Page 22848]]

codified into the conditions and limitations of exemption described in 
Sec.  878.4040(b)(1).
    N95s are the only devices included within the scope of the MOU. As 
such, this exemption only applies to devices currently regulated by FDA 
under product code MSH. This exemption does not affect any other subset 
of surgical apparel classified under Sec.  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 final 
order, these devices will also remain subject to current good 
manufacturing practices and other general controls under the FD&C Act. 
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.
    This exemption will decrease regulatory burdens on the medical 
device industry and will eliminate private costs and expenditures 
required to comply with Federal regulations. Specifically, regulated 
industry will no longer have to invest time and resources in 510(k)s, 
including preparation of documents and data for submission to FDA, 
payment of user fees associated with 510(k) submissions, and responding 
to questions and requests for additional information from FDA during 
510(k) review for devices in this exempted device type, subject to the 
conditions and limitations of the exemption.

VI. Paperwork Reduction Act of 1995

    This order refers to previously approved collections of information 
found in FDA regulations. These collections of information are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (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.

VII. 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 website addresses, as of the date this document publishes 
in the Federal Register, but websites 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, 21 CFR part 878 is 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, paragraph (b)(1) is revised to read as follows:


Sec.  878.4040  Surgical apparel.

* * * * *
    (b) Classification. (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: May 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10563 Filed 5-16-18; 8:45 am]
 BILLING CODE 4164-01-P



                                           22846               Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations

                                                Country                              Listed person and address                                  Federal Register citation and date of publication

                                                     *                     *                   *                 *                                   *              *             *
                                                                GenX Middle East FZE, a.k.a. GenX Systems LLC, #510–511                     83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
                                                                  Le Solarium Building, Dubai Silicon Oasis, Dubai, UAE;                      May 17, 2018.’’
                                                                  and P.O. Box 121225, Office M07, Al Zahra, Khaleed Bin
                                                                  Al Waleed Road, Bur Dubai, Dubai, UAE.
                                                                Roudah Al Hayat General Trading FZE, a.k.a. Rudha Al                        83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
                                                                  Hayat General Trading, a.k.a. Rouda Al Hayat General                        May 17, 2018.’’
                                                                  Trading, a.k.a. JSB Logistics, 406 Al Rhakaimi Building,
                                                                  Deira, Dubai, UAE; and #3204 Aspect Tower D, Sheikh
                                                                  Zayed Road, Dubai, UAE; and #1506 Aspect Tower D,
                                                                 Sheikh Zayed Road, Dubai, UAE and 901 Regal Tower,
                                                                  Business Bay, Dubai, UAE and 402 Al Fahad Building, Da-
                                                                  mascus Street, Dubai, UAE.

                                                     *                     *                 *                 *                                     *              *             *
                                                                TEM International FZC, Dubai Silicon Oasis Headquarters                     83 FR ‘‘[INSERT FEDERAL REGISTER PAGE NUMBER],
                                                                  Building, 4th Floor C&D Wings, P.O. Box 341041, Dubai,                      May 17, 2018.’’
                                                                  UAE.

                                                     *                      *                        *                      *                       *                      *                 *


                                             Dated: May 12, 2018.                                  industry and will eliminate private costs             paragraph (1)(B), FDA may exempt a
                                           Richard E. Ashooh,                                      and expenditures required to comply                   class II device from the requirement to
                                           Assistant Secretary for Export                          with certain Federal regulations. All                 submit a report under section 510(k) of
                                           Administration.                                         other class II devices classified under               the FD&C Act upon its own initiative or
                                           [FR Doc. 2018–10528 Filed 5–16–18; 8:45 am]             FDA’s surgical apparel classification                 a petition of an interested person, if
                                           BILLING CODE 3510–33–P                                  regulation continue to be subject to                  FDA determines that a report under
                                                                                                   premarket notification requirements.                  section 510(k) is not necessary to assure
                                                                                                   FDA is also amending the codified                     the safety and effectiveness of the
                                           DEPARTMENT OF HEALTH AND                                language for the surgical apparel devices             device. To do so, FDA must publish in
                                           HUMAN SERVICES                                          classification regulation to reflect this             the Federal Register notice of its intent
                                                                                                   final determination.                                  to exempt the device, or of the petition,
                                           Food and Drug Administration                            DATES: This order is effective May 17,                and provide a 60-calendar day period
                                                                                                   2018.                                                 for public comment. Within 120 days
                                           21 CFR Part 878                                                                                               after the issuance of the notice, FDA
                                                                                                   FOR FURTHER INFORMATION CONTACT:                      shall publish an order in the Federal
                                           [Docket No. FDA–2017–N–4919]                            Aftin Ross, Center for Devices and                    Register that sets forth its final
                                                                                                   Radiological Health, Food and Drug                    determination regarding the exemption
                                           Medical Devices; Exemption From                         Administration, 10903 New Hampshire
                                           Premarket Notification: Class II                                                                              of the device that was the subject of the
                                                                                                   Ave, Bldg. 66, Rm. 5402, Silver Spring,               notice.
                                           Devices; Surgical Apparel                               MD 20993, 301–796–5679, email:
                                                                                                   Aftin.Ross@fda.hhs.gov.                               II. Factors FDA May Consider for
                                           AGENCY:    Food and Drug Administration,
                                                                                                   SUPPLEMENTARY INFORMATION:
                                                                                                                                                         Exemption
                                           HHS.
                                           ACTION:   Final order.                                                                                           There are a number of factors FDA
                                                                                                   I. Statutory Background
                                                                                                                                                         may consider to determine whether a
                                           SUMMARY:   The Food and Drug                               Section 510(k) of the Federal Food,                510(k) is necessary to provide
                                           Administration (FDA or Agency) is                       Drug, and Cosmetic Act (FD&C Act) (21                 reasonable assurance of the safety and
                                           publishing this final order to exempt                   U.S.C. 360(k)) and the implementing                   effectiveness of a class II device. These
                                           certain surgical apparel from premarket                 regulations, 21 CFR part 807, subpart E,              factors are discussed in the January 21,
                                           notification requirements, subject to                   require persons who intend to market a                1998, Federal Register notice (63 FR
                                           conditions and limitations. FDA is                      new device to submit and obtain                       3142) and subsequently in the guidance
                                           limiting the exemption to single-use,                   clearance of a premarket notification                 the Agency issued on February 19, 1998,
                                           disposable respiratory protective                       (510(k)) containing information that                  entitled ‘‘Procedures for Class II Device
                                           devices (RPD) used in a healthcare                      allows FDA to determine whether the                   Exemptions From Premarket
                                           setting and worn by healthcare                          new device is ‘‘substantially equivalent’’            Notification; Guidance for Industry and
                                           personnel during procedures to protect                  within the meaning of section 513(i) of               CDRH Staff’’ (‘‘Class II 510(k)
                                           both the patient and the healthcare                     the FD&C Act (21 U.S.C. 360c(i)) to a                 Exemption Guidance’’) (Ref. 1).
                                           personnel from the transfer of                          legally marketed device that does not                 Accordingly, FDA generally considers
                                           microorganisms, body fluids, and                        require premarket approval.                           the following factors to determine
                                           particulate material. These devices,                       The 21st Century Cures Act (Pub. L.                whether a 510(k) is necessary for class
                                           commonly referred to as N95 filtering                   114–255) (Cures Act) was signed into                  II devices: (1) The device does not have
amozie on DSK3GDR082PROD with RULES




                                           facepiece respirators (FFRs) and surgical               law on December 13, 2016. Section 3054                a significant history of false or
                                           N95 respirators (herein collectively                    of the Cures Act amended section                      misleading claims or of risks associated
                                           referred to as N95s) are currently                      510(m) of the FD&C Act. As amended,                   with inherent characteristics of the
                                           regulated by FDA under product code                     section 510(m)(2) of the FD&C Act                     device; (2) characteristics of the device
                                           MSH. This exemption will decrease                       provides that, 1 calendar day after the               necessary for its safe and effective
                                           regulatory burden on the medical device                 date of publication of the final list under           performance are well established; (3)


                                      VerDate Sep<11>2014   16:58 May 16, 2018   Jkt 244001   PO 00000   Frm 00016   Fmt 4700   Sfmt 4700   E:\FR\FM\17MYR1.SGM   17MYR1


                                                               Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations                                         22847

                                           changes in the device that could affect                 MOU, the following definitions are                      One commenter requested that these
                                           safety and effectiveness will either: (a)               provided for the devices that are now                 devices still be subject to 510(k)
                                           Be readily detectable by users by visual                exempt.                                               requirements to ensure safety of people
                                           examination or other means such as                         The N95 FFR is a single-use                        using the disposable respiratory
                                           routine testing, before causing harm, or                disposable, half-mask respiratory                     protective devices. Further, the
                                           (b) not materially increase the risk of                 protective device that covers the user’s              commenter indicated that FDA’s
                                           injury, incorrect diagnosis, or ineffective             airway (nose and mouth) and offers                    proposal should not be finalized
                                           treatment; and (4) any changes to the                   protection from particulate materials at              because the sterility of these devices can
                                           device would not be likely to result in                 an N95 filtration efficiency level per 42             greatly affect those working in the
                                           a change in the device’s classification.                CFR 84.181. Such an N95 FFR used in                   health field and patients being treated,
                                           FDA may also consider that, even when                   a healthcare setting is a class II device,            and if these devices are not properly
                                           exempting devices, these devices would                  regulated by FDA under § 878.4040.                    inspected or regulated, diseases could
                                           still be subject to the limitations on                     The surgical N95 respirator is a                   spread more easily from person to
                                           exemptions.                                             single-use, disposable respiratory                    person. The commenter noted that
                                                                                                   protective device used in a healthcare                because these devices will be used by
                                           III. Device Description
                                                                                                   setting that is worn by HCP during                    surgical staff, it is even more important
                                              FDA, upon its own initiative, is                                                                           that the devices be inspected because
                                                                                                   procedures to protect both the patient
                                           exempting N95 filtering facepiece                                                                             surgery can involve open wounds or
                                                                                                   and HCP from the transfer of
                                           respirators (FFRs) and surgical N95                                                                           open body cavities, making it easier to
                                                                                                   microorganisms, body fluids, and
                                           respirators (herein collectively referred                                                                     spread disease or bodily fluids.
                                                                                                   particulate material at an N95 filtration
                                           to as N95s) from 510(k), subject to the                                                                         FDA notes in response to this
                                                                                                   efficiency level per 42 CFR 84.181. The
                                           conditions and limitations described in                                                                       commenter that N95s subject to this
                                                                                                   surgical N95 respirator is also a class II
                                           this section. FDA considers N95s to be                                                                        exemption from 510(k) are not provided
                                           a subset of ‘‘surgical apparel’’ intended               device, regulated by FDA under
                                                                                                                                                         sterile to the user. While FDA has
                                           to be worn by healthcare personnel to                   § 878.4040.
                                                                                                                                                         exempted these devices from 510(k), the
                                           protect both the patient and the                           In the Federal Register of November                scientific evidence necessary to legally
                                           healthcare personnel from transfer of                   30, 2017 (82 FR 56763), FDA published                 market N95s within this exemption has
                                           microorganisms, body fluids, and                        a proposed order announcing its intent                not changed. The majority of this testing
                                           particulate material. As a result, these                to exempt N95s from premarket                         has traditionally been reviewed by
                                           devices fall under the generic name                     notification [510(k)] requirements,                   NIOSH. The conditions and limitations
                                           ‘‘surgical apparel’’ and are classified in              subject to certain conditions and                     of exemption that FDA has identified in
                                           § 878.4040(b)(1) (21 CFR                                limitations, and provided opportunity                 section V of this final order and
                                           878.4040(b)(1)). In the Federal Register                for interested persons to submit                      § 878.4040(b)(1) will provide reasonable
                                           of June 24, 1988 (53 FR 23856), FDA                     comments by January 30, 2018. After                   assurance of safety and effectiveness for
                                           issued a final rule classifying surgical                reviewing the comments received                       N95s. Unless an N95 meets the mutually
                                           apparel into class II (special controls).               (summarized in section IV), FDA is now                agreed upon threshold evaluation
                                           We are now exempting a subset of                        providing its final determination for                 criteria and approval criteria and has
                                           surgical apparel devices currently                      N95s by exempting this type of device                 NIOSH approval, the device would still
                                           regulated under product code MSH from                   from 510(k) requirements, subject to                  be subject to 510(k) review.
                                           510(k) review. FDA has assessed the                     certain conditions and limitations as                 Accordingly, FDA did not modify the
                                           need for 510(k) against the criteria laid               identified in this final order. FDA is also           exemption or conditions and limitations
                                           out in the Class II 510(k) Exemption                    amending the codified language for the                of exemption proposed for N95s in
                                           Guidance and determined that these                      surgical apparel devices classification               response to this comment.
                                           devices no longer require a 510(k) to                   regulation to reflect this final
                                           provide reasonable assurance of safety                  determination. Persons with pending                   V. Conditions and Limitations of
                                           and effectiveness. However, this                        510(k) submissions for devices that are               Exemption
                                           exemption is limited and FDA’s                          now exempt from 510(k), subject to the                  As described in the MOU, the
                                           determination only applies to those                     conditions and limitations, should                    following conditions must be met for
                                           N95s under the conditions listed below.                 withdraw their submissions.                           N95s to be 510(k) exempt: (1)
                                              FDA has a Memorandum of                                                                                    application submitted to NIOSH is
                                                                                                   IV. Comments on the Proposed
                                           Understanding (MOU) with the Centers                                                                          determined not to exceed the CDC’s and
                                                                                                   Exemption and FDA’s Response
                                           for Disease Control and Prevention                                                                            FDA’s mutually agreed upon threshold
                                           (CDC), acting through its National                        In response to the November 2017                    evaluation criteria and (2) such
                                           Institute for Occupational Safety and                   proposed order announcing FDA’s                       applicants must have met approval
                                           Health (NIOSH), regarding oversight of                  intent to exempt N95s from 510(k)                     criteria and have NIOSH approval. N95s
                                           N95s (Ref. 2). This agreement outlines                  requirements, FDA received                            with applications that meet the
                                           the structure through which both                        submissions from four commenters—                     mutually agreed upon threshold
                                           Agencies will regulate N95s exempt                      two from regulated industry, one from                 evaluation criteria and approval criteria
                                           from 510(k). The MOU between NIOSH                      an industry association, and one from a               and remain approved by NIOSH are
                                           and FDA is now effective as part of this                consumer. Three commenters supported                  exempt from FDA’s 510(k)
                                           final order.                                            the implementation of the MOU with                    requirements. Unless an N95 meets the
                                              Although FDA and CDC share a                         the CDC, acting through NIOSH,                        mutually agreed upon threshold
                                           common public health mission, the                       regarding oversight of N95s and                       evaluation criteria and approval criteria
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                                           Agencies have different statutory                       exemption from 510(k) for this device                 and has NIOSH approval, the device is
                                           authorities and the distinct terminology                type. FDA agrees with the three                       subject to 510(k) review; this includes
                                           could lead to confusion among                           commenters that the exemption from                    devices with applications pending
                                           stakeholders. In order to clearly identify              510(k) requirements will streamline the               NIOSH review, as well as devices with
                                           the devices that are subject to this                    oversight of N95s without                             no submitted applications. The
                                           document, as well as the corresponding                  compromising the public health.                       threshold evaluation criteria are


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                                           22848               Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations

                                           codified into the conditions and                          1. FDA Guidance, ‘‘Procedures for Class II            (B) Demonstrate the ability of the
                                           limitations of exemption described in                   Device Exemptions from Premarket                      device to resist penetration by fluids,
                                           § 878.4040(b)(1).                                       Notification, Guidance for Industry and               such as blood and body fluids, at a
                                                                                                   CDRH Staff,’’ February 19, 1998, available at         velocity consistent with the intended
                                             N95s are the only devices included                    https://www.fda.gov/downloads/
                                           within the scope of the MOU. As such,                   MedicalDevices/DeviceRegulationand
                                                                                                                                                         use of the device.
                                           this exemption only applies to devices                  Guidance/GuidanceDocuments/                             (iii) NIOSH approved under its
                                           currently regulated by FDA under                        UCM080199.pdf.                                        regulation.
                                           product code MSH. This exemption                          2. ‘‘Memorandum of Understanding                    *      *    *     *    *
                                           does not affect any other subset of                     Between the Food and Drug Administration,
                                                                                                                                                           Dated: May 14, 2018.
                                           surgical apparel classified under                       Center for Devices and Radiological Health,
                                                                                                   and the Centers for Disease Control and               Leslie Kux,
                                           § 878.4040. In addition to being subject
                                           to the general limitations to the                       Prevention, National Institute for                    Associate Commissioner for Policy.
                                                                                                   Occupational Safety and Health, National              [FR Doc. 2018–10563 Filed 5–16–18; 8:45 am]
                                           exemptions found in 21 CFR 878.9 and                    Personal Protective Technology Laboratory,’’
                                           the conditions of exemption identified                  available at https://www.fda.gov/AboutFDA/
                                                                                                                                                         BILLING CODE 4164–01–P
                                           in this final order, these devices will                 PartnershipsCollaborations/
                                           also remain subject to current good                     MemorandaofUnderstandingMOUs/
                                           manufacturing practices and other                       DomesticMOUs/.                                        DEPARTMENT OF STATE
                                           general controls under the FD&C Act.
                                           An exemption from the requirement of                    List of Subjects in 21 CFR Part 878                   22 CFR Parts 50 and 51
                                           510(k) does not mean that the device is                    Medical devices.                                   [Public Notice 10417]
                                           exempt from any other statutory or                         Therefore, under the Federal Food,
                                           regulatory requirements, unless such                                                                          RIN 1400–AD54
                                                                                                   Drug, and Cosmetic Act (21 U.S.C. 321
                                           exemption is explicitly provided by                     et seq., as amended) and under
                                           order or regulation.                                                                                          Passports
                                                                                                   authority delegated to the Commissioner
                                             This exemption will decrease                          of Food and Drugs, 21 CFR part 878 is                 AGENCY:    Department of State.
                                           regulatory burdens on the medical                       amended as follows:                                   ACTION:   Final rule; stay.
                                           device industry and will eliminate
                                           private costs and expenditures required                 PART 878—GENERAL AND PLASTIC                          SUMMARY:   The Department of State
                                           to comply with Federal regulations.                     SURGERY DEVICES                                       published a final rule in the Federal
                                           Specifically, regulated industry will no                                                                      Register on May 11, 2018, amending the
                                           longer have to invest time and resources                ■ 1. The authority citation for part 878              passport rules for the Department of
                                           in 510(k)s, including preparation of                    continues to read as follows:                         State (the Department). The document
                                           documents and data for submission to                      Authority: 21 U.S.C. 351, 360, 360c, 360e,          stays the amendments in the May 11
                                           FDA, payment of user fees associated                    360j, 360l, 371.                                      rule until June 10, 2018.
                                           with 510(k) submissions, and                            ■ 2. In § 878.4040, paragraph (b)(1) is               DATES: Effective May 17, 2018,
                                           responding to questions and requests for                revised to read as follows:                           §§ 50.7(d), 50.11(b), 51.4(g)(1) and (8),
                                           additional information from FDA during                                                                        51.60(h) and (i), 51.62, 51.65, 51.66, and
                                           510(k) review for devices in this                       § 878.4040    Surgical apparel.
                                                                                                                                                         51.70 through 51.74, are stayed until
                                           exempted device type, subject to the                    *       *    *      *    *                            June 10, 2018.
                                           conditions and limitations of the                          (b) Classification. (1) Class II (special          FOR FURTHER INFORMATION CONTACT:
                                           exemption.                                              controls) for surgical gowns and surgical             Anita Mody, Office of Legal Affairs,
                                           VI. Paperwork Reduction Act of 1995                     masks. A surgical N95 respirator or N95               Passport Services, (202) 485–6500,
                                                                                                   filtering facepiece respirator is not                 PassportRules@state.gov. Hearing- or
                                             This order refers to previously                       exempt if it is intended to prevent                   speech-impaired persons may use the
                                           approved collections of information                     specific diseases or infections, or it is             Telecommunications Devices for the
                                           found in FDA regulations. These                         labeled or otherwise represented as                   Deaf (TDD) by contacting the Federal
                                           collections of information are subject to               filtering surgical smoke or plumes,                   Information Relay Service at 1–800–
                                           review by the Office of Management and                  filtering specific amounts of viruses or              877–8339.
                                           Budget (OMB) under the Paperwork                        bacteria, reducing the amount of and/or
                                           Reduction Act of 1995 (44 U.S.C. 3501–                  killing viruses, bacteria, or fungi, or               SUPPLEMENTARY INFORMATION: The
                                           3520). The collections of information in                affecting allergenicity, or it contains               Department of State published a final
                                           21 CFR part 807, subpart, E have been                   coating technologies unrelated to                     rule on May 11, 2018 (83 FR 21872),
                                           approved under OMB control number                       filtration (e.g., to reduce and or kill               which provided that the rule was
                                           0910–0120.                                              microorganisms). Surgical N95                         effective on the date of publication. This
                                                                                                   respirators and N95 filtering facepiece               document provides a stay of the
                                           VII. References                                                                                               amendments in that rule until 30 days
                                                                                                   respirators are exempt from the
                                             The following references are on                       premarket notification procedures in                  after the date of the May 11, 2018,
                                           display in the Dockets Management                       subpart E of part 807 of this chapter                 publication. The Regulatory Analysis
                                           Staff (see ADDRESSES) and are available                 subject to § 878.9, and the following                 published with that final rule is
                                           for viewing by interested persons                       conditions for exemption:                             unchanged by this publication.
                                           between 9 a.m. and 4 p.m., Monday                          (i) The user contacting components of              List of Subjects
                                           through Friday; they are also available                 the device must be demonstrated to be
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                                           electronically at https://                              biocompatible.                                        22 CFR Part 50
                                           www.regulations.gov. FDA has verified                      (ii) Analysis and nonclinical testing                Citizenship and naturalization.
                                           the website addresses, as of the date this              must:
                                           document publishes in the Federal                          (A) Characterize flammability and be               22 CFR Part 51
                                           Register, but websites are subject to                   demonstrated to be appropriate for the                  Administrative practice and
                                           change over time.                                       intended environment of use; and                      procedure, Drug traffic control,


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Document Created: 2018-05-17 00:50:26
Document Modified: 2018-05-17 00:50:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal order.
DatesThis order is effective May 17, 2018.
ContactAftin 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 Citation83 FR 22846 

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