‘Where’s the patient?’: Experts question FDA’s final recall guidance

MEDTECHDIVE – April 6, 2022 – By Ricky Zipp

While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system.

Medical device recalls and product safety issues have gained public attention over the last several years.

Patients, in particular, have questioned the recall process and criticized the FDA and industry after high-profile events highlighted inefficiencies in the system that put patient safety at risk.

Madris Kinard, CEO of Device Events, a company that compiles and interprets FDA medical device reports and recalls, also thought the inclusion of electronic communications was needed but added that the agency still did not go far enough to address the issue.  “I felt [the guidance] was not written strongly enough,” Kinard said, “because there are serious deficiencies with the recall processes, and moving to all electronic notifications is critical and long, long past due, and that wasn’t mandated or even encouraged as strongly as it needed to be.”

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