[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40061-40063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15891]


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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: Final order, determination.

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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, (``the January 15 notice'') which 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'') issued a Notice in the Federal 
Register of April 16, 2021 (``the April 16 notice'') explaining the 
basis for our current view that the seven types of reserved class I 
devices identified in the January 15 notice require a premarket 
notification, and explaining why the reasoning supporting the prior 
determination was unsound. HHS and FDA sought comment on the matters 
discussed in the April 16 notice, and have considered the comments that 
were submitted to the docket. HHS and FDA are issuing this final order 
and determination that the seven types of class I surgeon's gloves and 
patient examination gloves listed in the January 15 notice are reserved 
class I devices for which a premarket notification is required.

DATES: Compliance date: All devices subject to this order shall comply 
with the order no later than August 25, 2021.

ADDRESSES: 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, or by 
email at <a href="/cdn-cgi/l/email-protection#94c6c4d3d4f2f0f5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="96c4c6d1d6f0f2f7b8fefee5b8f1f9e0">[email protected]</span></a>.

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. The Medical 
Device Amendments of 1976 (``1976 amendments'') (Pub. L. 94-295), and 
the Safe Medical Devices Act of 1990 (Pub. L. 101-629), require FDA to 
classify devices 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 of Title 21 of the Code of Federal Regulations 
(CFR), require persons who intend to market a new device to submit a 
premarket notification (510(k)) demonstrating the new device is 
``substantially equivalent'' within the meaning of section 513(i) of 
the FD&C Act to a legally marketed device for which premarket approval 
is not required. Section 510(l)(1) of the FD&C Act, added to the 
statute by the Food and Drug Administration Modernization Act of 1997 
(FDAMA), provides that a 510(k) is not required for a class I device, 
except for any 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 except for class I 
device types that meet the reserved criteria under section 510(l)(1).
    As discussed in the April 16 notice, since 2017, FDA has evaluated 
which devices meet the reserved criteria several times. See 86 FR 20167 
at 20168. Each time, FDA has made its determinations available to the 
public through publication in the Federal Register. See 63 FR 5387, 63 
FR 63222, 65 FR 2296, 82 FR 17841, 84 FR 71794. In 1998, after FDAMA 
was enacted, FDA evaluated all class I devices in interstate commerce 
at that time, and published a notice in the Federal Register 
containing: (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 requirements. 
See 63 FR 5387. Although devices that did not meet the reserved 
criteria became exempt on February 19, 1998, FDA also issued proposed 
and final rules amending the applicable classification regulations for 
these devices, as well as for five device types that FDA had exempted 
prior to FDAMA that, post-FDAMA, FDA determined meet the reserved 
criteria. See 63 FR 63222, 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 paragraphs 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.

[[Page 40062]]

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. Accordingly, in 2017, FDA 
published in a notice in the Federal Register a list of class I device 
types that it has determined no longer meet the reserved criteria and 
are thus exempt from 510(k) (82 FR 17841). In 2019, FDA amended the 
classification regulations to reflect its exemption determinations.

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

    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) of the FD&C Act 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. As 
explained in the April 16 notice, section 510(l)(2) of the FD&C Act 
directs FDA to 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). See 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. Id.
    As discussed in the April 16 notice, the January 15 notice (86 FR 
4088) neither discussed the reserved criteria nor explained how HHS 
came to determine that 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 
notice contained no mention of or cite to this statutory standard, nor 
an explanation as to why it was left out. The April 16 notice discussed 
other procedural and substantive deficiencies in the January 15 notice 
that contributed to HHS's and FDA's decision to reverse the 
determinations made in that notice. For example, the January 15 notice 
relied solely upon adverse event reports in the Manufacturer and User 
Facility Device Experience (MAUDE) as its basis for determining the 
products to be exempt from 510(k), and then only adverse event reports 
for a very narrow period of time. While adverse event reports are a 
valuable source of information, the reports have limitations, including 
the potential submission of incomplete, inaccurate, untimely, 
unverified, or biased data. In addition, 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 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).

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

    In the April 16 notice, HHS and FDA announced our view that 
surgeon's gloves and patient examination gloves meet the reserved 
criteria, and sought comment on this determination. HHS and FDA 
received eight comments on that notice, all of which were supportive of 
the determination that surgeon's gloves and patient examination gloves 
meet the reserved criteria and are properly subject to premarket 
notification.
    As discussed in the April 16 notice, because of their importance in 
preventing impairment of human health, FDA has long considered 
surgeon's and patient examination gloves to meet the reserved criteria 
under section 510(l) and to be subject to the 510(k) requirement. See 
63 FR 5387, 63 FR 63222, 65 FR 2296. In 2017 and 2019, FDA evaluated 
all class I reserved devices to determine whether they continued to 
meet the reserved criteria. See 82 FR 17841, 84 FR 71794. FDA 
specifically evaluated the seven device types at issue based on its 
experiences with 510(k) submissions for the gloves, the risk inherent 
to the devices and the diseases they prevent, and other relevant 
considerations and determined that surgeon's gloves and patient 
examination gloves met the reserved criteria and therefore remained 
subject to premarket notification.
    HHS and FDA continue to believe that these gloves are of 
substantial importance in preventing impairment of human health or 
present a potential unreasonable risk of illness or injury and thus are 
subject to the reporting requirement under section 510(k) of the FD&C 
Act. Based on the risks inherent to 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 have 
determined 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 a report is required 
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, and can be the key barrier protecting against 
spreading infection (Refs. 1-3). See 21 CFR 878.4460 and 880.6250. As 
set forth in the April 16 notice, surgeon's gloves prevent against 
contamination in the operating room (Refs. 4 and 5), medical gloves 
protect against occupational exposure, for example, to chemotherapy 
drugs (Refs. 6 and 7), and these gloves play an important role in 
protecting the public. Review under section 510(k) is necessary to 
provide reasonable assurance of their safety and effectiveness, 
including by helping to assure that the identified gloves are durable 
and impermeable, among other things.
    Based on this evaluation and considering the comments submitted, 
HHS and FDA have made a final determination that surgeon's gloves and 
patient examination gloves meet the reserved criteria and therefore are 
subject to premarket notification.

IV. Further Information for Regulated Entities

    The gloves discussed in this notice are reserved, and as such, a 
510(k) is required for them. In general, FDA evaluates 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--including any gloves that are presented for import--after 
the compliance date of this order without premarket review, the Agency 
will consider and take appropriate enforcement action, taking into 
account the enforcement policy in its Guidance for Industry, 
``Enforcement Policy for

[[Page 40063]]

Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-
19) Public Health Emergency; Guidance for Industry and Food and Drug 
Administration Staff'' (Ref. 8).

V. 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., editor. Patient Safety and Quality: An Evidence-
Based Handbook for Nurses. Rockville (MD): Agency for Healthcare 
Research and Quality (US); 2008 April. Chapter 41. https://www.ncbi.nlm.nih.gov/books/NBK2683/pdf/Bookshelf_NBK2683.pdf.
4. Alexander, J. Wesley, Joseph S. Solomkin, and Michael J. Edwards 
(2011). ``Updated Recommendations for Control of Surgical Site 
Infections,'' Annals of Surgery, 253(6):1082-1093.
5. Sugarbaker, P.H. (2018). ``Increased Safety of Surgical Glove 
Application: The Under/Over Method'' Annals of the Royal College of 
Surgeons of England, 100(4):339-340.
6. Landeck, L., E. Gonzalez, and O.M. Koch. ``Handling Chemotherapy 
Drugs--Do Medical Gloves Really Protect?'' International Journal of 
Cancer. 2015 October 15;137(8):1800-5. doi: 10.1002/ijc.29058. Epub 
2014 July 22. PMID: 24978061
7. Nalin, M., G. Hug, E. Boeckmans, C. Machon, 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 Aug 26:1078155220950423. doi: 
10.1177/1078155220950423. Epub ahead of print. PMID: 32847481.
8. *FDA Guidance, ``Enforcement Policy for Gown, Other Apparel, and 
Gloves During the Coronavirus Disease (COVID-19) Public Health 
Emergency, Guidance for Industry and Food and Drug Administration 
Staff,'' March 25, 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.

    Dated: July 12, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.

    Dated: July 21, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-15891 Filed 7-23-21; 8:45 am]
BILLING CODE 4164-01-P


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