Document ID: FDA-2017-N-4919-0001
Agency: fda
Document Type: Proposed Rule
Title: Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel; Request for Comments
Posted Date: 2017-11-30T05:00Z

[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Proposed Rules]
[Pages 56763-56765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25781]

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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; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order; request for comments.

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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.gpo.gov/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