1 1 (April 2, 2020)

handle is hein.crs/govcqyr0001 and id is 1 raw text is: 





FF.ri E~$~                                &


                                                                                                     April 2, 2020

Personal Protective Equipment and Ventilators for COVID-19:

FDA Regulation and Related Activities


The Coronavirus Disease 2019 (COVID-19) pandemic has
affected the medical product supply chain both globally and
domestically. Perhaps most salient has been the impact of
COVID-19 on the availability of personal protective
equipment (PPE), such as gowns and masks, for health care
personnel, and respiratory devices, including ventilators, for
patients.
In the United States, respiratory devices and PPE used in
the health care setting meet the definition of a medical
device under the Federal Food, Drug, and Cosmetic Act
(FFDCA) and are regulated by the U.S. Food and Drug
Administration (FDA) within the Department of Health and
Human Services (HHS). This In Focus provides an
overview of how these devices are regulated and
summarizes the FDA response to mitigate reported PPE and
ventilator shortages related to COVID-19.
    F-A NY2            4    P   anc,  Vertx
In general, any company interested in distributing medical
PPE or ventilators a type of respiratory device-in the
United States would need permission from FDA. Pursuant
to its authorities in the FFDCA, FDA regulates medical
devices based on the risk they pose to consumers. There are
three regulatory classes of medical devices with different
applicable requirements: class I (low risk), class II
(moderate risk), and class III (high risk). Class II devices
are subject to special controls, and class III devices are
subject to premarket approval (PMA). However, all devices
regardless of regulatory class are subject to general controls
(e.g., establishment registration, good manufacturing
practices) unless exempt. Premarket notification, which
requires a 510(k) submission, is a type of general control
that applies to certain class I and most class II devices, and
requires manufacturers to submit certain materials to FDA
at least 90 days prior to marketing (21 U.S.C. 360(k)). To
receive a 510(k) clearance, the manufacturer must
demonstrate that the device proposed to be marketed is
substantially equivalent to a device already on the market.
Generally, a 510(k) submission includes the regulatory
class of the device, actions taken to comply with relevant
performance standards, proposed labeling, and a statement
describing how the device is similar to or different from a
predicate device, among other things (21 C.F.R. 807.87).
There are certain circumstances under which a change to an
existing device would require a new 5 10(k) submission.
According to FDA guidance, such changes include, among
other things, labeling, technology, and/or materials used.


PPE refers to single-use protective gowns, gloves, masks,
and respirators intended to block transmission of infection


from blood, body fluids, or respiratory secretions.
Regulatory requirements vary by type of PPE, which are
generally class I or II devices.
Medical gloves are used to protect an individual from the
spread of infection during medical procedures and
examinations. Medical gloves are class I devices that
require a 5 10(k) clearance, and include patient examination
gloves (21 C.F.R. 880.6250) and surgical gloves (21
C.F.R. 878.4460).
Medical gowns (21 C.F.R. 878.4040) are a type of
surgical apparel used to protect against infection or illness
if contact with infectious liquid or solid material is likely.
Manufacturers are encouraged to comply with national
consensus standards so their gowns provide any one of four
levels of protection: level 1 (minimal risk), level 2 (low
risk), level 3 (moderate risk), and level 4 (high risk). While
medical gown terminology is not standardized, FDA
generally regulates medical gowns in three categories:
* Nonsurgical gowns are intended for use in low- or
   minimal-risk patient isolation situations (level 1-2) and
   are class I devices exempt from premarket review (i.e.,
   510(k) notification or PMA approval).
* Surgical isolation gowns are used in moderate- to high-
   risk situations (level 3-4) and are class II devices subject
   to 5 10(k) notification and special controls (e.g.,
   performance standards).
* Surgical gowns are generally used during surgical
   procedures but can be used for any risk level (levels 1-4)
   and are class II devices subject to 5 10(k) notification
   and special controls.
Face masks are a broad category of PPE that include
surgical masks and filtering facepiece respirators (FFRs).
FFRs and other respirators for occupational use (e.g., N95
FFRs) are subject to certification and approval by the
National Institute for Occupational Safety and Health
(NIOSH). FFRs intended for nonmedical or general public
use are not subject to FDA oversight.
FFRs intended for medical use (e.g., surgical N95 FFRs)
are subject to both NIOSH approval and FDA regulation as
devices. Surgical masks and surgical N95 FFRs (21 C.F.R.
878.4040 and 878.6260) both class II medical devices
requiring 510(k) notification, unless exempt provide a
physical barrier to fluids and particulate matter by covering
the nose or mouth. Both are tested for fluid resistance,
filtration efficiency, flammability, and biocompatibility.
Surgical masks are loose-fitting, while surgical N95 FFRs
form a tight seal around the nose and mouth, providing very
efficient filtration (i.e., 95%) of airborne particles.


mppm qq\
        ' p\w -- ' gn'a', g-o
                I
'S
11LULANJILiN,

What Is HeinOnline?

HeinOnline is a subscription-based resource containing nearly 2,700 academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline with pricing starting as low as $29.95

Access to this content requires a subscription. Please visit the following page to request a quote or trial:

Already a HeinOnline Subscriber?