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 modifications.
- 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 appropriate.
- 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 [email protected] 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.
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