[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Rules and Regulations]
[Pages 22846-22848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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