MedTech Dive March 18, 2024
Experts said improving how adverse events are tracked and requiring manufacturers to use electronic notifications could make devices safer.
Lawmakers and patients have called for scrutiny of the Food and Drug Administration’s medical device recall oversight after several high-profile recalls in the last five years. The U.S. Government Accountability Office said in January it would look into the agency’s oversight of medical device recalls, a little over a decade after a previous investigation by the watchdog found the FDA often failed to conduct recall-related inspections and document why a recall was terminated.
Recent safety problems with devices have gotten lawmakers’ attention again. Philips is still resolving a recall of more than 15 million sleep apnea machines and ventilators due...
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