On March 22, 2020, the U.S. Food and Drug Administration (FDA) published
guidance that relieves manufacturers of FDA-cleared ventilator products of
the requirement to submit a premarket notification (510(k)) prior to making
certain changes to their cleared products. The guidance also encourages
manufacturers of ventilator support products not currently marketed in the
United States and non-medical device manufacturers to contact FDA regarding
potentially obtaining an emergency use authorization (EUA) to manufacture
and provide ventilator support products in the United States. FDA issued
this guidance in response to the rapidly growing number of COVID-19 cases
that may require mechanical ventilation, which has the potential to quickly
overwhelm health systems across the country.
Here are four key takeaways from FDA’s guidance.
- FDA exercised enforcement discretion regarding certain premarket
notification requirements. Normally, when a manufacturer makes a modification to a ventilator that
could significantly affect the safety or efficacy of the device, it may
need to submit a FDA 510(k) for premarket review before the modified
product is marketed or sold in the United States. This typically creates a
significant delay in the time that it takes to provide modified products to
patients. The guidance allows companies with FDA-cleared ventilator
products to make changes to those products without submitting a premarket
510(k) notification before introducing the modified products into the
market. Specifically, the guidance permits manufacturers to make
modifications to motors or other electrical components, add filtration,
modify software, utilize different materials in the construction of the
ventilators, and implement remote monitoring capabilities without
submitting a 510(k) for the modification where the modification would not
create an undue risk in light of the public health emergency. The guidance
also addresses the standards FDA expects manufacturers to follow in
designing, evaluating, and validating these changes, including labeling
- FDA does not intend to object to certain modifications to the
indications, claims, or functionality of certain FDA-cleared products. FDA noted that ventilators may be indicated for use in non-cleared
environments. For example, ventilators designed for use in an ambulance or
for short-term emergency use may be repurposed for long-term use, and
ventilators intended for use at home may be repurposed for use in a
healthcare facility. FDA also suggested that devices intended to treat
sleep apnea, including continuous positive airway pressure (CPAP) devices,
may be used to treat respiratory insufficiency (provided design mitigations
are in place to address aerosolization) and that oxygen concentrators may
be used for primary supply when medically necessary or clinically
- FDA will allow manufacturers to market products beyond their indicated
shelf life. Manufacturers will be allowed to market certain ventilators and
anesthesia gas machines, components and accessories beyond their originally
indicated shelf lives, provided they are otherwise used in accordance with
healthcare facilities’ institutional protocols and their useful life is
limited to the occurrence of a malfunction or visible device soiling.
- FDA encouraged foreign and domestic manufacturers
to talk to FDA about pursuing an emergency use authorization, which
would allow them to manufacture and distribute ventilators within the
United States. Manufacturers should reach out to FDA at
CDRH-COVID19-Ventilators@fda.hhs.gov regarding whether to pursue an EUA to allow them to distribute ventilators
that currently lack FDA clearance or approval, regardless of whether the
manufacturer has previously manufactured medical devices. FDA provides
suggestions for information manufacturers should include in their email,
such as product labeling, whether the product is cleared or approved in
another jurisdiction, whether the device complies with FDA-recognized
performance standards and complies with FDA’s quality system regulation (21
CFR Part 820) or ISO 13485, and whether the device is designed with a power
supply suitable for use in the United States. The guidance leaves open the
possibility that FDA will temporarily allow entities that currently
manufacture ventilators and market them outside the United States to begin
distributing ventilators in the United States prior to receipt of an EUA.
FDA intends to notify ex-U.S. ventilator manufacturers if they are eligible
for this pre-EUA enforcement discretion. Entities not previously engaged in
medical device manufacturing, however, will still be required to obtain an
EUA before marketing ventilators in the United States.
“With this boost from the FDA, medical device makers can more easily make
changes to existing products, such as changes to suppliers or materials, to
help address current manufacturing limitations or supply shortages,"
Department of Health and Human Services Secretary Alex Azar said in a
statement. "Other manufacturers, such as auto makers, can more easily
repurpose production lines to help increase supply."
Taken altogether, the actions as outlined in the guidance demonstrate FDA’s
flexibility during this pandemic to help manufacturers and encourage
increased production of ventilators. This guidance is one of many actions
FDA has taken to increase the availability of medical devices, including
diagnostic supplies and personal protective equipment.
McGuireWoods has a dedicated team of lawyers who will continue to monitor
the approval and availability of COVID-19 countermeasures, as well as
official guidance at the state and federal levels. Please reach out to our
team if you have any questions.
McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial COVID-19-related business and legal issues.