FDA No Longer Accepting Certain Face Mask EUAs, Signaling A More Manageable Pandemic

Source : Medtech Insight

The US Food and Drug Administration has updated its emergency use authorization (EUA) list of imported disposable filtering facepiece respirators (FFRs) for health care workers for the last time. The decision signals the agency is less concerned about shortages as the pandemic has become more manageable.

From the start of the coronavirus pandemic, the FDA has published lists of personal protective equipment (PPE) that have been allowed on the market through EUAs, including certain face masks under “Exhibit 1” listed on the agency’s website.

Initially the FDA took a very broad position on what PPE, and face masks more specifically, could be allowed on the market, as there was grave concern over shortages. However, the agency now says it has updated the list of face masks that fall under the EUA for the last time and won’t review new face mask EUA applications anymore.

“On March 24, 2021, the FDA revised this EUA to authorize for emergency-use only those respirators listed in the EUA's Exhibit 1 as of the date of this reissuance,” the agency said. “The FDA will no longer be reviewing requests and adding new respirator models to Exhibit 1 of this EUA.”

Exactly a year ago, the FDA issued its umbrella EUA for certain imported disposable filtering facepiece respirators (FFRs) that are not approved by the National Institute for Occupational Safety and Health (NIOSH). The EUA was specifically for respirators for frontline health care personnel to help mitigate shortages. ()

Since then, the agency has updated the EUA several times to tweak what face masks are allowed to stay on the market. ()

The FDA revised the EUA in March 2020 so certain decontaminated respirators that are cleaned using authorized decontamination systems could be reused for health care workers. ()

A few months later, in June 2020, the agency again revised its EUA to exclude decontaminated respirators with exhalation valves from the scope of the authorization. At the time the FDA said that due to concerns about the design and performance of respirators that remained on its list of authorized FFRs, Chinese-made respirators could no longer be reused after decontamination. ()

As the number of new daily COVID-19 cases have fallen from 200,000 to fewer than 60,000, and the percentage of people who have been fully vaccinated for SARS-CoV-2 grows exponentially, it seems the FDA is less concerned about a surge in new cases that could again put a strain on the supply of face masks.

More broadly, the FDA appears to be pushing EUA sponsors to start applying for traditional premarket applications to keep their product on the market, signaling that the pandemic could be waning. () and ()

By Ferdous Al-Faruque