James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “FDA Class I Medical Device Recalls on Track to Break Record in 2021,” by Ana Mulero. (Read the full version – subscription required.)

Following is an excerpt:

Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The agency is now working to remediate the interruptions resulting from the pandemic among certain manufacturers of high-risk medical devices in reporting these recalls to the FDA. …

Interruptions with notification and reporting

A delay in reporting recalls to the FDA because of the pandemic was almost to be expected, noted James Boiani, an attorney at Washington-based law firm Epstein Becker & Green PC, told BioWorld.

"There was an understanding that some of the submissions that the FDA would be getting might be delayed because the people who needed to do them couldn't get to work or had clients who had experienced COVID-19 outbreaks at their facilities that hampered their abilities," Boiani said. "There might have been some unwritten latitude" driving delays in reporting, also, Boiani added. …

2021 likely to set a record …

"I think the FDA will leverage remote audits going forward as a way to keep further oversight in a cost-effective manner of the manufacturers," Boiani added. But it is going to start showing up at the door again, too, especially for more complex manufacturing sites. "Now, any latitude companies have been getting over the last 18 months is winding down to business as usual."

Similarly, the number of FDA warning letters is expected to see a significant increase this year.


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