Notice2021-15891
Medical Devices; Class I Surgeon's and Patient Examination Gloves
Primary source
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Published
July 26, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
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<title>Federal Register, Volume 86 Issue 140 (Monday, July 26, 2021)</title>
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[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40061-40063]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
<a href="https://www.who.int/gpsc/5may/Glove_Use_Information_Leaflet.pdf">https://www.who.int/gpsc/5may/Glove_Use_Information_Leaflet.pdf</a>.
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. <a href="https://www.ncbi.nlm.nih.gov/books/NBK2683/pdf/Bookshelf_NBK2683.pdf">https://www.ncbi.nlm.nih.gov/books/NBK2683/pdf/Bookshelf_NBK2683.pdf</a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-gowns-other-apparel-and-gloves-during-coronavirus-disease-covid-19-public-health</a>.
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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