[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Pages 20167-20172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07759]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-Z-0025]


Medical Devices; Class I Surgeon's and Patient Examination Gloves

AGENCY: Department of Health and Human Services (HHS), Food and Drug 
Administration (FDA).

ACTION: Notice; request for comments.

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SUMMARY: The Department of Health and Human Services (HHS or ``the 
Department'') issued a Notice in the Federal Register of January 15, 
2021, that, among other things, identified seven types of reserved 
class I devices that the Department had determined no longer require 
premarket notification. The Department and the Food and Drug 
Administration (FDA or ``the Agency'') have reviewed the prior 
determination, including the record supporting it, and believe that the 
determination is flawed. This notice explains the basis for HHS and 
FDA's current view that the seven types of reserved class I devices 
identified in the January 15, 2021, Notice require a premarket 
notification, and explains why the reasoning supporting the prior 
determination was unsound. HHS and FDA are seeking comment on the 
matters discussed in this notice and will issue a future notice in the 
Federal Register containing a final determination regarding the class I 
medical gloves listed in the January 15, 2021, Notice.

DATES: Submit either electronic or written comments on this Notice by 
May 17, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Comments must be 
submitted by May 17, 2021. The https://www.regulations.gov electronic 
filing system will accept comments until 11:59 p.m. Eastern Time at the 
end of May 17, 2021. 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.

Electronic Submissions

    Submit electronic comments in the following way:
     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-2021-Z-0025 for ``Medical Devices; Class I Reserved Surgeon's and 
Patient Examination Gloves.'' 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

[[Page 20168]]

Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     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 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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1660, Silver Spring, MD 20993, 301-796-6380, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background Regarding Section 510(l) of the FD&C Act

    Under section 513 of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360c), FDA must classify devices into one of three 
regulatory classes: Class I, class II, or class III. FDA classification 
of a device is determined by the amount of regulation necessary to 
provide a reasonable assurance of safety and effectiveness. Under the 
Medical Device Amendments of 1976 (Pub. L. 94-295) and the Safe Medical 
Devices Act of 1990 (Pub. L. 101-629), devices are classified into 
class I (``general controls'') if there is information showing that the 
general controls of the FD&C Act are sufficient to assure safety and 
effectiveness; into class II (``special controls''), if general 
controls, by themselves, are insufficient to provide reasonable 
assurance of safety and effectiveness, but there is sufficient 
information to establish special controls to provide such assurance; 
and into class III (premarket approval), if there is insufficient 
information to support classifying a device into class I or class II 
and the device is a life sustaining or life supporting device, or is 
for a use which is of substantial importance in preventing impairment 
of human health, or presents a potential unreasonable risk of illness 
or injury.
    Unless a device is exempt from premarket notification, section 
510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing 
regulations, part 807 (21 CFR part 807), require persons who intend to 
market a new device to submit a premarket notification (510(k)) 
demonstrating that the new device is ``substantially equivalent'' 
within the meaning of section 513(i) of the FD&C Act to a legally 
marketed device that does not require premarket approval. Section 
510(l) of the FD&C Act, added to the statute by the Food and Drug 
Administration Modernization Act of 1997 (FDAMA and now codified as 
section 510(l)(1), provides that a 510(k) is not required for a class I 
device, except for a class I device intended for a use that is of 
substantial importance in preventing impairment of human health, or any 
class I device that presents a potential unreasonable risk of illness 
or injury. FDA refers to these as the ``reserved criteria'' and to 
class I devices subject to 510(k) as ``class I reserved devices.'' 
Thus, class I devices are exempt from the 510(k) requirements unless a 
class I device type meets the reserved criteria under section 510(l)(1) 
of the FD&C Act.
    After the enactment of FDAMA, FDA evaluated all class I devices in 
interstate commerce at that time to determine which device types met 
the reserved criteria. On February 2, 1998, FDA published in a notice 
in the Federal Register: (1) A list of device types that FDA believed 
met the reserved criteria and thus would remain subject to premarket 
notification and (2) a list of device types that FDA believed did not 
meet these criteria and thus would be exempt from such requirement as 
of February 19, 1998 (the statutory effective date for what is now 
section 510(l)(1)) (63 FR 5387). As part of the evaluation, where FDA 
determined a device type did not meet the reserved criteria, FDA also 
considered limitations on that exemption--that is, the circumstances 
under which an exempt device could, depending on the device's intended 
use or potential unreasonable risk, meet the reserved criteria and thus 
remain subject to the premarket notification requirement (63 FR 5387 at 
5388 to 5389). Although devices that did not meet the reserved criteria 
became exempt on February 19, 1998, the February 2, 1998, notice 
invited public comment on FDA's determinations concerning the status of 
various class I devices. On November 12, 1998, FDA published a proposed 
rule to amend the applicable classification regulations in the Code of 
Federal Regulations to designate which class I devices require 
premarket notification and which devices are exempt from premarket 
notification under section 510(l) of the FD&C Act (63 FR 63222). This 
took into account FDA's determinations in the February 1998 notice, 
comments received in response to that notice, and other information 
available to the Agency. At the same time, FDA evaluated devices the 
Agency had, prior to FDAMA, exempted from the premarket notification 
requirement by rulemaking. FDA determined that five such device types 
met the reserved criteria and thus proposed to amend the applicable 
classification regulations accordingly (63 FR 63222). FDA issued a 
final rule amending those classification regulations on January 14, 
2000 (65 FR 2296).
    On December 13, 2016, the 21st Century Cures Act (Cures Act) 
amended section 510(l) of the FD&C Act, reorganizing section 510(l) 
into subsections 510(l)(1) and (2). Section 510(l)(2) of the FD&C Act 
requires FDA to identify at least once every 5 years, through 
publication in the Federal Register, any type of class I device that 
the Agency determines no longer requires a report under section 510(k) 
of the FD&C Act to provide reasonable assurance of safety and 
effectiveness. Section 510(l)(2) of the FD&C Act further provides that 
upon publication of the Agency's determination in the Federal Register, 
these devices shall be exempt from 510(k) and the classification 
regulation applicable to each such type of device shall be deemed 
amended to incorporate such exemption. Following the enactment of the 
Cures Act, FDA published in a notice in the Federal Register a list of

[[Page 20169]]

class I device types that it had determined no longer meet the reserved 
criteria and are thus exempt from 510(k) (82 FR 17841, April 13, 2017). 
In 2019, FDA amended the classification regulations to reflect the 
exemption determinations (84 FR 71794, December 30, 2019). That final 
order and amendment also addressed exemption determinations for class 
II devices, which are subject to a different process.

II. Criteria for Exemption From Section 510(k) of the FD&C Act

    FDA has explained, following the enactment of both FDAMA and the 
Cures Act, that it determines whether class I devices are subject to, 
or exempt from, 510(k) based on the reserved criteria. The Department 
concurs. As previously noted, the statute sets forth the relevant 
criteria for when a class I device is subject to section 510(k) of the 
FD&C Act. Specifically, section 510(l)(1) of the FD&C Act provides that 
a class I device is not exempt from the premarket notification 
requirements of section 510(k) if the device is intended for a use that 
is of substantial importance in preventing impairment of human health, 
or it presents a potential unreasonable risk of illness or injury (63 
FR 5387, 82 FR 17841).
    Because all devices must have a reasonable assurance of safety and 
effectiveness (see discussion regarding classification and the level of 
regulation necessary to provide such assurance in section I of this 
document), the reserved criteria delineate which class I devices 
require a 510(k) to provide a reasonable assurance of safety and 
effectiveness and which do not. Thus, the directive in section 
510(l)(2) of the FD&C Act that FDA must identify class I devices it 
determines no longer require a report under section 510(k) to provide 
reasonable assurance of safety and effectiveness means that FDA must 
identify which class I devices that FDA previously determined meet the 
reserved criteria no longer meet these criteria, in which case a 510(k) 
is no longer required to provide reasonable assurance of safety and 
effectiveness. FDA has explained that in determining whether either of 
these criteria are met, the Agency considers for example, its 
experience in reviewing premarket notifications for each device, 
focusing on the risk inherent with the device and the disease being 
treated or diagnosed (e.g., devices with rapidly evolving technology or 
expansions of intended uses) (63 FR 5387, 82 FR 17841). The Agency also 
considers the history of adverse event reports under the medical device 
reporting program for these devices, as well as their history of 
product recalls.

III. Determination Regarding Surgeon's Gloves and Patient Examination 
Gloves and Premarket Notification

    Based on the risks inherent with surgeon's gloves and patient 
examination gloves and the diseases being prevented, FDA's experience 
with these devices, and other relevant considerations, HHS and FDA 
believe that gloves with the product codes LYY, LYZ, OIG, OPC, OPH, 
LZC, and OPA are intended for uses which are of substantial importance 
in preventing impairment of human health or present a potential 
unreasonable risk of illness or injury and thus require a report under 
section 510(k) of the FD&C Act. Surgeon's gloves and patient 
examination gloves are generally intended to prevent contamination and 
the spread of pathogens (see 21 CFR 878.4460 and 880.6250). They can be 
the key barrier that protects against the spread of infection between 
individuals, including infections transmitted through bodily fluids, 
such as hepatitis or human immunodeficiency virus (HIV) (Refs. 1-3). 
Surgeon's gloves, in particular, prevent against contamination in the 
operating room, where patients are highly vulnerable to infection 
(Refs. 4 and 5). Medical gloves also serve other key purposes, such as 
protecting against occupational exposure to chemotherapy drugs, which 
have potential mutagenic, carcinogenic, and teratogenic effects (Refs. 
6 and 7). Thus, these gloves play an important role in preventing risks 
to the public, and 510(k) review is necessary to provide reasonable 
assurance of their safety and effectiveness, including by helping to 
assure that the gloves are durable and impermeable, among other things.
    Because of their importance in preventing impairment of human 
health, FDA has long considered these seven types of gloves to meet the 
reserved criteria under section 510(l) of the FD&C Act and to be 
subject to the 510(k) requirement. In 1998, after considering its 
experience in reviewing premarket notifications for those devices, as 
well as the history of adverse event reports and recalls, FDA 
determined that surgeon's gloves and patient examination gloves meet 
the reserved criteria (63 FR 5387). FDA invited comments on the 
February 2, 1998, Notice, and received no comments regarding gloves. 
When FDA proposed to amend the classification regulations in November 
1998 to reflect its determinations as to which class I devices were 
exempt and which were not (63 FR 63222), FDA again received no comments 
regarding these surgeon's gloves and patient examination gloves. FDA's 
January 2000 final rule to amend the classification regulations 
reflected this determination (65 FR 2296).
    Following the enactment of the Cures Act, in 2017, FDA again 
evaluated all class I reserved devices to determine whether they 
continued to meet the reserved criteria. In doing so, FDA identified a 
number of class I devices that, based on the considerations discussed 
above, do not meet those criteria and thus no longer require premarket 
notification (82 FR 17841). FDA also considered applicable limitations 
for the device types that it determined were exempt. During this 
evaluation, FDA specifically considered the seven types of gloves 
discussed above. FDA took into account its experiences with 510(k) 
submissions for the gloves, the risk inherent with the devices and the 
diseases they prevent, and other relevant considerations. After 
conducting this evaluation, FDA determined that surgeon's gloves and 
patient examination gloves met the reserved criteria and therefore 
remained subject to premarket notification.
    FDA has issued an enforcement policy concerning these gloves in 
response to the COVID-19 public health emergency (PHE). However, this 
policy, which is limited in duration and scope, is fundamentally 
different from a determination that the gloves no longer meet the 
reserved criteria or otherwise no longer require a 510(k). Enforcement 
policies communicate an Agency's nonbinding views about how it should 
allocate its enforcement resources based on current facts and 
circumstances. Such policies do not alter the legal obligation to 
comply with the relevant requirements and do not preclude the Agency 
from taking action to enforce those requirements where appropriate. 
This particular enforcement policy was issued in response to a highly 
unusual set of facts and circumstances: The most sweeping PHE to occur 
in over a century. The public health threat posed by COVID-19, the 
disease caused by the SARS-CoV-2 virus, is substantial. Global demand 
for infection control measures has increased significantly and is a 
critical part of the response to the COVID-19 outbreak. FDA's March 
2020 guidance entitled ``Enforcement Policy for Gown, Other Apparel, 
and Gloves During the Coronavirus Disease (COVID-19) Public Health 
Emergency'' (``Gloves PHE Guidance'') provides information, 
recommendations, and policies to help address the urgent need for 
appropriate clinical management and infection control and to help

[[Page 20170]]

expand the availability of surgical apparel for healthcare 
professionals during the COVID PHE (Ref. 8).
    Specifically for gloves, the guidance explains that it should help 
expand the availability of certain gloves to help address the urgent 
public health concerns caused by shortages of such products by taking a 
risk-based approach to them. In issuing this policy, FDA sought to 
balance the various public health considerations related to the PHE and 
specifically limited the policy to the duration of the PHE. As part of 
this balancing, the Agency also limited the enforcement policy in 
scope. In the guidance, FDA stated its intention not to object to the 
distribution and use of certain patient examination gloves \1\ and 
surgeon's gloves \2\ that do not comply with the premarket notification 
requirements of section 510(k) where the products ``do not create an 
undue risk in light of the public health emergency.'' FDA then 
identified factors in determining whether such gloves could create 
undue risk, such as whether the gloves are labeled for use with 
chemotherapy drugs, fentanyl, and other opioids, use for allergy or 
dermatitis prevention, use for antimicrobial or antiviral protection, 
or use for infection prevention or reduction.
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    \1\ The policies in the Gloves PHE Guidance apply to those 
patient examination gloves with product codes FMC, LYY, LZA, LZB, 
LYZ, OIG, OPC, OPH, and LZC.
    \2\ The policies in the Gloves PHE Guidance apply to those 
surgeon's gloves with product codes KGO and OPA.
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    As with all FDA guidance, the Agency invited public comment at any 
time. FDA has not received any comments on the guidance that such 
gloves, rather than being subject to an enforcement policy, should be 
exempt from the premarket notification requirement because they do not 
meet the reserved criteria. More broadly, given the context in which 
the guidance was issued and the limitations in its scope and duration, 
this policy does not diminish the important legal and policy reasons 
for determining that surgeon's gloves and patient examination gloves 
are required to have a 510(k). If in March 2020 FDA had believed that 
the gloves no longer met the reserved criteria and thus were exempt 
under the statute, the Agency could have undertaken the process 
specified in 510(l)(2) of the FD&C Act; instead it chose an enforcement 
policy, which reflected FDA's careful balancing of the public-health 
considerations in response to the PHE.

IV. Issues Raised by HHS's January 15, 2021, Notice

    On January 15, 2021, HHS published a notice (``the January 15, 
2021, Notice'' or ``Notice'') (86 FR 4088) determining that six types 
of reserved class I patient examination gloves with the product codes 
LYY, LYZ, OIG, OPC, OPH, and LZC, and one type of reserved class I 
surgeon's glove device with the product code OPA, no longer require a 
report under section 510(k) of the FD&C Act. We did not find any 
evidence that HHS consulted with, otherwise involved, or even notified 
FDA before issuing the Notice. The Notice explained that HHS based 
these exemption determinations on its conclusion that premarket 
notification is no longer required to provide reasonable assurance of 
the safety and effectiveness of these devices, which it in turn based 
solely on its evaluation of adverse events in FDA's Manufacturer and 
User Facility Device Experience database (MAUDE). HHS concluded that 
the fact that there were few if any (depending on the glove type) 
adverse events reported in MAUDE following FDA's issuance of its Gloves 
PHE Guidance meant that premarket notification is no longer required to 
provide a reasonable assurance of the safety and effectiveness of these 
devices. The January 15, 2021, Notice did not discuss any applicable 
limitations on the exemption for gloves, or even discuss whether it 
considered that issue.
    HHS and FDA have now reexamined the January 15, 2021, Notice, 
including its class I exemption determinations, and believes it is 
appropriate to reverse these determinations. This reexamination was 
prompted primarily by two things. One is that certain staff and 
leadership in FDA's Center for Devices and Radiological Health that 
conduct regulatory oversight of personal protective equipment, 
including the types of gloves covered in the Notice, identified the 
flaws below and brought them to the Department's attention. The other 
is that HHS has received dozens of inquiries about the January 15, 
2021, Notice, both formally through https://www.regulations.gov as well 
as directly to the contact listed in that Notice and to various FDA 
staff and FDA program email addresses.
    Comments received regarding the seven types of gloves support HHS 
and FDA's position that these gloves remain subject to 510(k). 
Generally, comments received to date note the risk of leaching 
chemotherapy drugs, the risk of radiation exposure, and the importance 
of barrier protection from infection. One comment remarked on the 
unreliability of adverse event data alone. Further, the direct 
inquiries indicate a pattern of uncertainty about whether the class I 
devices described in the Notice are exempt. In addition, some 
commenters expressed confusion about the Notice, such as why the Notice 
discussed some, but not all, of the product codes for surgeon's gloves 
and patient examination gloves covered by the Gloves PHE Guidance. For 
example, some commenters asked whether this was intentional or 
inadvertent, finding no explanation in the Notice. Other inquiries 
asked whether, regardless of the Notice, FDA would review new 510(k) 
premarket notifications voluntarily submitted for such devices and/or 
whether FDA would continue its review of already-submitted premarket 
notifications. HHS and FDA believe that the determinations in the 
January 15, 2021, Notice lack adequate legal and scientific support, 
and that the Notice is otherwise flawed, for the reasons explained 
below.
    First, the January 15, 2021, Notice neither discusses the reserved 
criteria nor explains how HHS came to determine the gloves no longer 
meet the reserved criteria; i.e., that the gloves are not intended for 
a use that is of substantial importance in preventing impairment of 
human health, or do not present a potential unreasonable risk of 
illness or injury. The January 15, 2021, Notice contains no mention of 
or cite to this statutory standard, nor an explanation as to why it was 
left out. Moreover, even under the standard applied--``reasonable 
assurance of safety and effectiveness''--the Notice did not consider 
the gloves' effectiveness.
    Second, as mentioned above, in evaluating a device to determine 
whether it is exempt, FDA has considered its experience in reviewing 
premarket notifications, focusing on the risk inherent with the device 
and the disease being treated or diagnosed, as well as other relevant 
considerations, including the history of adverse event reports for 
these products and their history of product recalls. The January 15, 
2021, Notice, however, HHS relied solely upon adverse event reports in 
MAUDE as its basis for determining the products to be exempt from 
510(k). Although adverse event reports are a valuable source of 
information, the reports have limitations, as noted in the January 15, 
2021, Notice, including the potential submission of incomplete, 
inaccurate, untimely, unverified, or biased data. The incidence or 
prevalence of an event cannot be determined from adverse event reports 
alone, due to underreporting of events, inaccuracies in reports, lack 
of

[[Page 20171]]

verification that the device caused the reported event, and lack of 
information about frequency of device use. Adverse event data is not 
adequate on its own for assessing safety, let alone whether to 
determine a device to be exempt from 510(k). The Notice does not, for 
example, take into account FDA's experience in reviewing 510(k)s for 
these devices, which FDA typically does with a focus on the risk 
inherent with the device and the relevant disease(s) being treated or 
diagnosed, or the products' recall history. FDA recognized, in a 
previous regulatory action, that certain gloves may pose an 
unreasonable risk of illness or injury when it banned powdered 
surgeon's gloves and powdered patient examination gloves (see 81 FR 
91722, December 19, 2016).
    Further, even on its own terms, the adverse event information 
proffered to support the January 15, 2021, Notice has key limitations. 
For example, some subset of the gloves on the market following issuance 
of the Gloves PHE Guidance would have entered the market prior to 
issuance of the guidance and thus gone through 510(k) review. For that 
subset, there is no reason to anticipate any change in adverse event 
reports based on the guidance because they were cleared by FDA. The 
January 15, 2021, Notice assumes that new or modified gloves, which had 
never undergone 510(k) review, entered the market following the Gloves 
PHE Guidance in significant enough proportions that they would skew the 
adverse-event trends had 510(k) been necessary to assure safety and 
effectiveness. But the Notice does not explain the basis for this 
assumption. There is no indication the adverse event evaluation 
considered whether or how many new or changed gloves entered the market 
during this time that would justify the Notice's overall conclusions. 
In addition, the Notice did not explain why it was reasonable to draw 
conclusions based on adverse events for these products in such a narrow 
time period, which was from whenever any new or modified gloves started 
to be used after the March 30, 2020, guidance until November 30, 2020, 
which was the end of the adverse event review period. Likewise, the 
Notice did not address other potential data limitations, such as the 
likelihood that adverse event reporting has been more difficult during 
a public health emergency and thus may have been more limited than 
usual. FDA discussed the challenges of adverse event reporting during a 
pandemic in its guidance, issued in May 2020, entitled, ``Postmarketing 
Adverse Event Reporting for Medical Products and Dietary Supplements 
During a Pandemic.'' \3\
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    \3\ Although January 15, 2021, Notice concluded that 510(k)s are 
no longer necessary for these devices ``[i]n view of the complete 
lack of or de minimis number of adverse events in MAUDE following 
[the March 2020 Gloves PHE Guidance],'' the adverse event tables in 
the Notice included adverse events going back to 2010. To the extent 
that the quantity of adverse events between 2010 and 2020 informed 
the conclusion in the Notice regarding the need for 510(k) for the 
class I gloves, the discussion in this paragraph would not apply. 
However, this would not impact our analysis of the other flaws in 
the Notice or our view that these gloves meet the reserved criteria.
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    Finally, we did not find any evidence that HHS consulted with or 
otherwise involved FDA in its exemption determination or issuance of 
the Notice. Section 1003(d) of the FD&C Act (21 U.S.C. 393(d)) provides 
that the Secretary ``shall be responsible for executing'' the FD&C Act 
``through the [FDA] Commissioner.'' Here, the Notice is clearly an 
action ``executing'' the FD&C Act. Moreover, it is particularly 
important that FDA have at least some level of involvement in this type 
of an action given the expertise needed to evaluate whether particular 
device types meet the reserved criteria.
    In evaluating whether the gloves discussed in the January 15, 2021, 
Notice require a report under section 510(k) of the FD&C Act, the 
Department and FDA have considered regulated entities' reliance on the 
Notice. As an initial matter, HHS and FDA observe that, as described 
above, the Notice contained a number of flaws that have led to 
significant questions about the status of these devices. HHS and FDA 
have not only received over 60 inquiries about the Notice, reflecting a 
pattern of uncertainty, but have also received requests for review of 
510(k) premarket notifications that have been voluntarily submitted for 
such devices. Based on these facts, HHS and FDA believe that only a 
limited subset of regulated entities may have placed legitimate 
reliance on the January 15, 2021, Notice. For any such entities, given 
the short time period between now and when the Notice was issued, HHS 
and FDA also believe that few (if any) long-term investments, 
contracts, or other significant business decisions relying on the 
Notice are likely to have been made. Furthermore, to the extent that 
any such decisions have been made, HHS and FDA strongly believe that 
those interests cannot outweigh the directive of the statute for FDA to 
review class I devices that meet the reserved criteria, and also cannot 
outweigh the public-health importance of conducting 510(k) review for 
these devices, for the reasons discussed in section III above. 
Elsewhere in this issue of the Federal Register, HHS and FDA are 
announcing the withdrawal of the proposed exemptions for the 83 class 
II devices and 1 unclassified device included in the January 15, 2021, 
Notice.

V. Further Information for Regulated Entities

    HHS and FDA are concerned about the public health risks posed by 
the January 15, 2021, Notice, particularly as the Notice applies to 
medical gloves that could pose undue risk as described in the Gloves 
PHE Guidance. HHS and FDA remind regulated entities that various 
requirements under the FD&C Act and FDA regulations apply to the class 
I medical gloves described in this notice, regardless of their status 
under section 510(k) and (l). For example, section 502(a) and (f)(1) of 
the FD&C Act prohibits device labeling that is false or misleading in 
any particular or that lacks adequate directions for use (21 U.S.C. 
352(a) and (f)(1)). Section 201(n) of the FD&C Act provides that, in 
determining whether labeling is misleading, ``there shall be taken into 
account (among other things) not only representations made or 
suggested. . .but also the extent to which the labeling or advertising 
fails to reveal facts material in the light of such representations or 
material with respect to consequences which may result from the use of 
the article. . . .'' (21 U.S.C. 321(n)). FDA regulations further 
provide that ``[a]mong representations in the labeling of a device 
which render such device misbranded is a false or misleading 
representation with respect to another device or a drug or food or 
cosmetic'' (21 CFR 801.6). Regulated entities should bear in mind that 
device labeling that makes certain representations or fails to disclose 
certain information could misbrand the product in violation of the FD&C 
Act and FDA regulations. FDA emphasizes the importance of compliance 
with these requirements with respect to the gloves that are the subject 
of this notice. For more information concerning the labeling of class I 
medical gloves during the COVID-19 PHE, please see the Gloves PHE 
Guidance.
    Furthermore, because of the potential risks posed by gloves that 
have not undergone FDA's premarket review, FDA intends to increase its 
surveillance of the seven types of gloves subject to the January 15, 
2021, Notice, taking into account its enforcement policy in the Gloves 
PHE Guidance. This increased surveillance could, for example, include a 
labeling review and a physical examination to assess for physical

[[Page 20172]]

defects. Because we expect that most such gloves are imported, FDA's 
focus will be on products at the time of importation. We also draw your 
attention to the guidance from 2008 entitled ``Surveillance and 
Detention Without Physical Examination of Surgeons' and/or Patient 
Examination Gloves'', which also discusses the acceptable quality 
criteria defined in 21 CFR 800.20 for the importation of gloves (Ref. 
9). Nothing in this Notice alters the legal obligation to comply with 
the relevant statutory requirements and does not preclude the Agency 
from taking action to enforce those requirements where appropriate.
    If the gloves discussed in this notice meet the reserved criteria, 
such gloves require a 510(k). Following consideration of the comments, 
FDA intends to issue a future notice in the Federal Register containing 
its final determination concerning whether these seven types of gloves 
are reserved. Previously, during 510(k) review for these types of 
gloves, FDA has evaluated the dimensional and physical properties of 
the gloves, and nonclinical data regarding barrier performance, 
biocompatibility, and residual powders, among other information, to 
support the safety and effectiveness of the gloves for their intended 
use. FDA also evaluates the indications for use and labeling to ensure 
the devices are appropriately labeled, consistent with their intended 
use. For any gloves that are distributed after FDA issues its final 
determination, the Agency would consider and take appropriate 
enforcement action, taking into account the enforcement policy in the 
Gloves PHE Guidance.

VI. References

    The following references marked with an asterisk (*) are on display 
at 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 also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. 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. Centers for Disease Control, ``Perspectives in Disease Prevention 
and Health Promotion Update: Universal Precautions for Prevention of 
Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and 
Other Bloodborne Pathogens in Health-Care Settings.'' Morbidity and 
Mortality Weekly Report, 1988; 37(25):377-388.
2. World Health Organization, ``Glove Use Information Leaflet.'' 
2009. https://www.who.int/gpsc/5may/Glove_Use_Information_Leaflet.pdf.
3. Collins, A.S., ``Preventing Health Care-Associated Infections.'' 
In: Hughes, R.G., Ed. Patient Safety and Quality: An Evidence-Based 
Handbook for Nurses. Rockville (MD): Agency for Healthcare Research 
and Quality (U.S.); April 2008, chapter 41.
4. Alexander, J.W., J.S. Solanki, and M.J. Edwards, ``Updated 
Recommendations for Control of Surgical Site Infections,'' Annals of 
Surgery, 253(6):1082-1093, 2011.
5. Sugarbaker, P.H., ``Increased Safety of Surgical Glove 
Application: The Under/Over Method,'' Annals of the Royal College of 
Surgeons of England, 100(4):339-340, 2018.
6. Landeck, L., E. Gonzalez, and O.M. Koch, ``Handling Chemotherapy 
Drugs--Do Medical Gloves Really Protect?'' International Journal of 
Cancer, 137(8):1800-1805, 2015. doi: 10.1002/ijc.29058. Epub 2014 
July 22. PMID: 24978061.
7. Nalin, M., G. Hug, E. Boeckmans, et al., ``Permeation Measurement 
of 27 Chemotherapy Drugs After Simulated Dynamic Testing on 15 
Surgical and Examination Gloves: A Knowledge Update,'' Journal of 
Oncology Pharmacy Practice, 2020 August 26:1078155220950423. doi: 
10.1177/1078155220950423. Epub ahead of print. PMID: 32847481.
8. *FDA Guidance for Industry and FDA Staff, ``Enforcement Policy 
for Gowns, Other Apparel, and Gloves During the Coronavirus Disease 
(COVID-19) Public Health Emergency,'' March 2020; available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health.
9. *FDA Guidance for Industry and FDA Staff, ``Surveillance and 
Detention Without Physical Examination of Surgeons' and/or Patient 
Examination Gloves,'' July 2008; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/surveillance-and-detention-without-physical-examination-surgeons-andor-patient-examination-gloves.

    Dated: April 12, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
    Dated: April 12, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-07759 Filed 4-15-21; 8:45 am]
BILLING CODE 4164-01-P