Personal Protective Equipment (PPE) and COVID-19: FDA Regulation and Related Activities

Personal Protective Equipment (PPE) and COVID-19: FDA Regulation and Related Activities

Updated September 22, 2020
Personal Protective Equipment (PPE) and COVID-19: FDA
Regulation and Related Activities
The Coronavirus Disease 2019 (COVID-19) pandemic has
Regulatory requirements vary by type of PPE, which are
affected the medical product supply chain globally and
generally class I or II devices.
domestically. The impact of COVID-19 on the availability
of personal protective equipment (PPE), such as gowns,
Medical Gloves
gloves, respirators, and surgical masks, for health care
Medical gloves are used to protect the wearer from the
personnel continues to be a concern.
spread of infection during medical procedures and
examinations. Medical gloves are class I devices that
PPE is generally worn by health care personnel to protect
require a 510(k) clearance, and include patient examination
the wearer from infection or illness from blood, body fluids,
gloves (21 C.F.R. §880.6250) and surgical gloves (21
or respiratory secretions. In the United States, PPE intended
C.F.R. §878.4460).
for use in the cure, mitigation, treatment, or prevention of
disease meet the definition of a medical device (device)
Medical Gowns
under the Federal Food, Drug, and Cosmetic Act (FFDCA)
Medical gowns (21 C.F.R. §878.4040) are a type of surgical
and are regulated by the U.S. Food and Drug
apparel used to protect against infection or illness if contact
Administration (FDA) within the Department of Health and
with infectious liquid or solid material is likely.
Human Services (HHS). PPE that do not meet the FFDCA
definition of device (i.e., not intended for medical use) are
Manufacturers are encouraged to comply with national
not regulated by FDA. This In Focus provides an overview
consensus standards so their gowns provide any one of four
of how FDA regulates PPE and summarizes the agency’s
levels of protection: level 1 (minimal risk), level 2 (low
response to mitigate reported PPE shortages related to
risk), level 3 (moderate risk), and level 4 (high risk). While
COVID-19.
medical gown terminology is not standardized, FDA
generally regulates medical gowns in three categories:
FDA Regulation of PPE
 Nonsurgical gowns are intended for use in minimal-to-
In general, any company interested in distributing medical
low risk patient isolation situations (level 1-2) and are
PPE in the United States would need permission from FDA.
class I devices exempt from premarket review (i.e.,
Pursuant to its authorities in the FFDCA, FDA regulates
510(k) notification or PMA approval).
medical devices based on the risk they pose to consumers.
There are three regulatory classes of devices with different
 Surgical isolation gowns are used in moderate- to high-
applicable requirements: class I (low risk), class II
risk situations (level 3-4) and are class II devices subject
(moderate risk), and class III (high risk). Class II devices
to 510(k) notification and certain special controls (e.g.,
are subject to special controls, and class III devices are
performance standards).
subject to premarket approval (PMA). However, all devices
 Surgical gowns are generally used during surgical
regardless of regulatory class are subject to general controls
procedures but can be used for any risk level (levels 1-4)
(e.g., establishment registration, good manufacturing
and are class II devices subject to 510(k) notification
practices) unless exempt. Premarket notification, which
and certain special controls.
requires a 510(k) submission, is a general control that
applies to certain class I and most class II devices, and
Surgical Masks and Filtering Facepiece Respirators
requires manufacturers to submit certain materials to FDA
at least 90 days prior to marketing (21 U.S.C. §360(k)). To
Masks are a broad category of PPE that include surgical
receive a 510(k) clearance, a manufacturer must
masks and filtering facepiece respirators (FFRs). FFRs
demonstrate that the device proposed to be marketed is
intended for medical use (e.g., surgical N95 FFRs) are
substantially equivalent to a device already on the market.
subject to both National Institute for Occupational Safety
and Health (NIOSH) approval and FDA regulation as
In general, a 510(k) submission includes the regulatory
devices. Surgical masks and surgical N95 FFRs (21 C.F.R.
class of the device, actions taken to comply with relevant
§§878.4040 and 880.6260)—both class II medical devices
performance standards, proposed labeling, and a statement
requiring 510(k) notification, unless exempt—provide a
describing how the device is similar to or different from a
physical barrier to fluids and particulate matter by covering
predicate device, among other things (21 C.F.R. §807.87).
the nose or mouth. Both are tested for fluid resistance,
There are certain circumstances under which a change to an
filtration efficiency, flammability, and biocompatibility.
existing device would require a new 510(k) submission.
Surgical masks are loose-fitting, while surgical N95 FFRs
According to FDA guidance, such changes include, among
form a tight seal around the nose and mouth, providing very
other things, labeling, technology, and/or materials used.
efficient filtration (i.e., 95%) of airborne particles.
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Personal Protective Equipment (PPE) and COVID-19: FDA Regulation and Related Activities
Face masks intended for nonmedical or public use generally
consideration of each EUA request for protective barrier
are not subject to FDA oversight. FFRs and other
enclosures would better protect the public health.
respirators for occupational use (e.g., N95s for industrial
use) are subject to NIOSH approval but not FDA oversight.
Considerations for Congress
Availability of and access to PPE has been a concern
FDA Response to Address PPE Shortage throughout the COVID-19 pandemic. PPE shortages have
FDA has taken various steps to prevent and mitigate
presented challenges for both health care personnel treating
shortages of critical PPE. FDA cannot compel firms to
patients in medical settings and expansion of COVID-19
make PPE, although the agency may expedite review,
testing. Looking forward, the federal government may
enable access to unapproved devices, and exercise
encounter similar challenges if a COVID-19 vaccine
regulatory flexibility to reduce barriers to market entry.
becomes available in the near future.
Through emergency use authorization (EUA), FDA has
Until recently, FDA’s ability to monitor potential device
enabled access to PPE that have not received agency
shortages was limited, at least compared to drugs. For
clearance (21 U.S.C. §360bbb–3). For example, FDA has
example, unlike drug manufacturers, medical device
issued several EUAs allowing the distribution and use—as
manufacturers had not been required to report to FDA
PPE in health care settings by health care personnel during
interruptions in manufacturing or product discontinuances.
the COVID-19 pandemic—of certain NIOSH-approved
The Coronavirus Aid, Relief, and Economic Security
respirators typically not intended for medical use; certain
(CARES) Act (P.L. 116-136) expanded FDA’s authority to
imported respirators that are not FDA-cleared or NIOSH-
address shortages of PPE and other medical devices.
approved; and systems for decontaminating respirators
Specifically, the law requires manufacturers of certain
intended for single use. FDA also has issued umbrella
devices—those that are critical during a public health
EUAs covering surgical masks, face shields, and other
emergency or for which FDA determines that information
protective barriers that meet certain performance standards.
on potential meaningful supply disruptions is needed
Because FDA modifies, revokes, and grants new EUAs as
during, or in advance of a public health emergency—to
the agency deems appropriate, this In Focus is not intended
report to FDA interruptions and discontinuances in
to track all PPE EUAs.
manufacturing. It also explicitly authorizes FDA to take
certain actions to mitigate shortages and requires FDA to
To further expand availability of PPE, FDA also has issued
make public a list of devices that are in shortage, which the
enforcement policies through guidance documents that
agency did for the first time on August 14, 2020, specific to
further describe conditions under which entities may
devices in shortage during the COVID-19 public health
manufacture and distribute PPE during the COVID-19
emergency. Congress could consider expanding reporting
public health emergency without complying with certain
requirements in future legislation to include requiring
FDA requirements, such as clearance or registration.
manufacturers of medical devices to report to FDA actual
Generally, distributing these devices without complying
or forecasted increases in demand that may lead to a
with such requirements would be a violation of the FFDCA
shortage or actions taken by other regulatory authorities that
and FDA regulations, subject to enforcement action.
could affect U.S supply (e.g., export restrictions).
However, FDA states it will not take enforcement action
during the COVID-19 outbreak if the entity distributing the
As mentioned, FDA cannot require an entity to make or
covered PPE complies with the criteria specified in
increase production of a device, and FDA alone likely
guidance (e.g., fluid standards testing).
cannot address ongoing supply chain concerns. However,
While FDA’s actions have allowed additional
other mechanisms in federal law may be used to increase
entities to
domestic production of PPE and other medical devices. One
produce PPE for the U.S. market, waiving or modifying
example is the Defense Production Act (DPA), which is
regulatory requirements is not without risk and may affect
described in more detail in other CRS products. In addition,
the safety, effectiveness, and quality of PPE. Throughout
various legislative proposals have been introduced in the
the duration of the COVID-19 pandemic, FDA has
116th Congress to address concerns about vulnerabilities in
amended and revoked EUAs for medical products as the
the medical product supply chain. These proposals include,
agency has received new scientific information about them.
among other things, commissioning studies; expanding
For example, on April 3, 2020, FDA issued an EUA
manufacturer reporting requirements and information
allowing certain non-NIOSH-approved and non-FDA-
sharing across agencies; restricting federal health programs
cleared respirators to be imported from China in order to
from purchasing foreign-made medical products; and
address reported shortages. However, FDA subsequently
expanding and incentivizing domestic manufacturing.
amended the EUA to exclude certain previously authorized
respirators because they failed to demonstrate adequate
A more detailed discussion of FDA’s role in the medical
filtration performance in testing conducted by NIOSH.
product supply chain can be found in CRS Report R46507,
Similarly, on May 1, 2020, FDA issued an umbrella EUA
FDA’s Role in the Medical Product Supply Chain and
for use of protective barrier enclosures, by health care
Considerations During COVID-19, by Victoria R. Green,
personnel in health care settings, that would provide an
Agata Dabrowska, and Kate M. Costin.
extra layer of barrier protection in addition to PPE. Such
barrier enclosures were authorized for use when caring for
Agata Dabrowska, Analyst in Health Policy
or performing medical procedures on patients with known
Victoria R. Green, Analyst in Health Policy
or suspected COVID-19 to prevent exposure to pathogenic
IF11488
biological airborne particulates. On August 20, 2020, FDA
revoked the umbrella EUA, determining that individual
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Personal Protective Equipment (PPE) and COVID-19: FDA Regulation and Related Activities

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https://crsreports.congress.gov | IF11488 · VERSION 2 · UPDATED