April 2, 2020
Personal Protective Equipment and Ventilators for COVID-19:
FDA Regulation and Related Activities
The Coronavirus Disease 2019 (COVID-19) pandemic has
from blood, body fluids, or respiratory secretions.
affected the medical product supply chain both globally and
Regulatory requirements vary by type of PPE, which are
domestically. Perhaps most salient has been the impact of
generally class I or II devices.
COVID-19 on the availability of personal protective
Medical gloves are used to protect an individual from the
equipment (PPE), such as gowns and masks, for health care
spread of infection during medical procedures and
personnel, and respiratory devices, including ventilators, for
examinations. Medical gloves are class I devices that
patients.
require a 510(k) clearance, and include patient examination
In the United States, respiratory devices and PPE used in
gloves (21 C.F.R. §880.6250) and surgical gloves (21
the health care setting meet the definition of a medical
C.F.R. §878.4460).
device under the Federal Food, Drug, and Cosmetic Act
Medical gowns (21 C.F.R. §878.4040) are a type of
(FFDCA) and are regulated by the U.S. Food and Drug
Administration (FDA) within the Department of Health and
surgical apparel used to protect against infection or illness
Human Services (HHS). This In Focus provides an
if contact with infectious liquid or solid material is likely.
overview of how these devices are regulated and
Manufacturers are encouraged to comply with national
summarizes the FDA response to mitigate reported PPE and
consensus standards so their gowns provide any one of four
ventilator shortages related to COVID-19.
levels of protection: level 1 (minimal risk), level 2 (low
risk), level 3 (moderate risk), and level 4 (high risk). While
FDA Regulation of PPE and Ventilators
medical gown terminology is not standardized, FDA
In general, any company interested in distributing medical
generally regulates medical gowns in three categories:
PPE or ventilators—a type of respiratory device—in the
 Nonsurgical gowns are intended for use in low- or
United States would need permission from FDA. Pursuant
minimal-risk patient isolation situations (level 1-2) and
to its authorities in the FFDCA, FDA regulates medical
are class I devices exempt from premarket review (i.e.,
devices based on the risk they pose to consumers. There are
510(k) notification or PMA approval).
three regulatory classes of medical devices with different
applicable requirements: class I (low risk), class II
 Surgical isolation gowns are used in moderate- to high-
(moderate risk), and class III (high risk). Class II devices
risk situations (level 3-4) and are class II devices subject
are subject to special controls, and class III devices are
to 510(k) notification and special controls (e.g.,
subject to premarket approval (PMA). However, all devices
performance standards).
regardless of regulatory class are subject to general controls
 Surgical gowns are generally used during surgical
(e.g., establishment registration, good manufacturing
procedures but can be used for any risk level (levels 1-4)
practices) unless exempt. Premarket notification, which
and are class II devices subject to 510(k) notification
requires a 510(k) submission, is a type of general control
and special controls.
that applies to certain class I and most class II devices, and
requires manufacturers to submit certain materials to FDA
Face masks are a broad category of PPE that include
at least 90 days prior to marketing (21 U.S.C. §360(k)). To
surgical masks and filtering facepiece respirators (FFRs).
receive a 510(k) clearance, the manufacturer must
FFRs and other respirators for occupational use (e.g., N95
demonstrate that the device proposed to be marketed is
FFRs) are subject to certification and approval by the
substantially equivalent to a device already on the market.
National Institute for Occupational Safety and Health
(NIOSH). FFRs intended for nonmedical or general public
Generally, a 510(k) submission includes the regulatory
use are not subject to FDA oversight.
class of the device, actions taken to comply with relevant
performance standards, proposed labeling, and a statement
FFRs intended for medical use (e.g., surgical N95 FFRs)
describing how the device is similar to or different from a
are subject to both NIOSH approval and FDA regulation as
predicate device, among other things (21 C.F.R. §807.87).
devices. Surgical masks and surgical N95 FFRs (21 C.F.R.
There are certain circumstances under which a change to an
§§878.4040 and 878.6260)—both class II medical devices
existing device would require a new 510(k) submission.
requiring 510(k) notification, unless exempt—provide a
According to FDA guidance, such changes include, among
physical barrier to fluids and particulate matter by covering
other things, labeling, technology, and/or materials used.
the nose or mouth. Both are tested for fluid resistance,
filtration efficiency, flammability, and biocompatibility.
Personal Protective Equipment (PPE)
Surgical masks are loose-fitting, while surgical N95 FFRs
PPE refers to single-use protective gowns, gloves, masks,
form a tight seal around the nose and mouth, providing very
and respirators intended to block transmission of infection
efficient filtration (i.e., 95%) of airborne particles.
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Personal Protective Equipment and Ventilators for COVID-19: FDA Regulation and Related Activities
Ventilators
FDA is working with other agencies on the federal response
Ventilators and their accessories (21 C.F.R. Part 868,
to increase availability of PPE and ventilators. For example,
Subpart F) assist patients experiencing respiratory
FDA is working with the Federal Emergency Management
difficulties with breathing either manually or by mechanical
Agency (FEMA) on supply chain issues, including
control in a health care or home setting. In contrast to PPE,
importation of medical products to support the U.S.
which are intended to be protective devices, ventilators and
response. FDA also has provided instructions to
their accessories are intended to mitigate respiratory
manufacturers interested in importing PPE and other
symptoms associated with COVID-19. Ventilators and their
devices, clarifying what information needs to be submitted
accessories are generally class II devices subject to 510(k)
to FDA and/or U.S. Customs and Border Protection (CBP).
notification and certain special controls. Unlike PPE,
Considerations for Congress
ventilators and their accessories are generally reusable,
subject to certain requirements.
Until recently, FDA’s ability to monitor potential device
shortages was limited, at least compared to drugs. For
FDA Response to Address Shortages of
example, unlike drug manufacturers, medical device
PPE and Respiratory Devices
manufacturers have not been required to report to FDA
FDA and other agencies have taken various steps to prevent
interruptions in manufacturing or product discontinuances.
and mitigate shortages of critical PPE and respiratory
The Coronavirus Aid, Relief, and Economic Security
devices, examples of which are provided in this section.
(CARES) Act (P.L. 116-136) expands FDA’s authority to
address shortages of PPE and other medical devices.
FDA cannot compel firms to make PPE or ventilators,
Specifically, the law requires manufacturers of certain
although it may expedite review, enable access to
devices—those that are critical during a public health
unapproved devices, and exercise regulatory flexibility to
emergency or for which FDA determines that information
reduce barriers to market entry. Through emergency use
on potential meaningful supply disruptions is needed
authorization (EUA), FDA has enabled access to respirators
during, or in advance of a public health emergency—to
and ventilators that have not received agency clearance (21
report to FDA interruptions and discontinuances in
U.S.C. §360bbb–3). As of the date of this In Focus, three
manufacturing. It also explicitly authorizes FDA to take
EUAs are in effect for respirators and one for ventilators.
certain actions to mitigate shortages and requires FDA to
Together, the three EUAs for respirators authorize the
make public a list of devices that are in shortage. Congress
use—in health care settings by health care personnel during
could consider expanding reporting requirements in future
the COVID-19 outbreak—of (1) certain NIOSH-approved
legislation to include requiring manufacturers of medical
FFRs not regulated by FDA and those that have passed the
devices (and drugs) to report to FDA actual or forecasted
recommended shelf life, as well as certain NIOSH-
increases in demand that may lead to a shortage or actions
approved air purifying respirators; (2) certain imported
taken by other regulatory authorities that could affect U.S
FFRs that are not NIOSH-approved; and (3) the Battelle
supply (e.g., export restrictions).
Decontamination System for compatible N95 or equivalent
respirators. The EUA concerning ventilators authorizes use
Congress also could further reduce barriers to market entry
of ventilators; anesthesia gas machines and positive
for devices. However, FDA has already waived various
pressure breathing devices modified for use as ventilators;
requirements, in some cases allowing for distribution and
ventilator tubing connectors; and ventilator accessories not
purchase of devices that have not been reviewed by the
currently marketed in the United States or that are currently
agency for safety or effectiveness. In addition, waiving
marketed in the United States, but have been modified in a
regulatory requirements is not without risk and may affect
way that would trigger a new 510(k) submission.
the safety, effectiveness, or quality of PPE and ventilators.
Furthermore, some recommendations issued by FDA may
FDA has described in guidance the conditions under which
conflict with those of physician groups and other
entities may distribute nonrespirator face masks, gloves,
stakeholders. For example, the American Society of
gowns, and other apparel without 510(k) clearance or
Anesthesiologists issued guidance in February 2020
registering with the agency. Generally, distributing these
discouraging the use of CPAP machines among COVID-19
devices without registration and FDA clearance would be a
patients, citing concerns that the devices may increase the
violation of the FFDCA and FDA regulations, subject to
spread of COVID-19 by pumping the virus into the air.
enforcement action. However, FDA states it will not take
enforcement action during the COVID-19 outbreak if the
As mentioned, FDA cannot require an entity to make or
entity distributing the covered PPE complies with the
increase production of a device. However, other
criteria specified in guidance (e.g., fluid standards testing).
mechanisms in federal law allow for required increases in
production. One example is the Defense Production Act
FDA also has sent letters to health care providers
(DPA), which was invoked by President Trump on March
recommending strategies to conserve gowns and masks, as
18, 2020 (see CRS Insight IN11231, The Defense
well as describing how they may consider alternative
Production Act (DPA) and COVID-19: Key Authorities and
devices for patients requiring respiratory support if
Policy Considerations).
ventilators are in shortage. For example, subject to
appropriate monitoring, emergency transport ventilators,
Agata Dabrowska, Analyst in Health Policy
anesthesia gas machines, and continuous positive airway
Victoria R. Green, Analyst in Health Policy
pressure (CPAP) machines could be used.
IF11488
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Personal Protective Equipment and Ventilators for COVID-19: FDA Regulation and Related Activities


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https://crsreports.congress.gov | IF11488 · VERSION 1 · NEW

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