FDA can’t explain drop in device recalls, but experts point to COVID disruptions

Medical Design & Outsourcing – July 6, 2022 – By Danielle Kirsh 

The FDA acknowledged interruptions with notifications from recalling firms during the pandemic, while regulatory experts point to fewer inspections and fewer procedures.

FDA medical device product recalls dropped last year to their lowest level since 2013, according to a Medical Design & Outsourcing analysis of recall data from the regulatory agency.

Medtech regulatory experts said the COVID-19 pandemic showed room for improvement in FDA oversight and postmarket surveillance of medical devices.

Device products recalled in fiscal year 2021 (ended Sept. 30, 2021) totaled 2,607, a 14.3% decrease from the 3,042 recalls reported in fiscal 2020.

Making the difficult call

Some devices may have stayed on the market longer than they should have due to a fear of shortages in healthcare facilities during the pandemic, said Madris Kinard, the founder and CEO of Device Events and a former unique device identification (UDI) external program manager and adverse events SME for medical devices at the FDA.

“The companies are making these decisions, and then the FDA might review them, but isn’t necessarily taking an active enough approach,” Kinard said.

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