Medical Errors

Delay in reporting medical device malfunctions to FDA

Agreement would ease FDA requirements for reporting medical device malfunctions.

The New York Times (7/11, Kaplan, Subscription Publication, 13.9M) reports “an agreement headed for a vote in Congress” would give medical device makers the ability to “delay reporting dangerous malfunctions to the Food and Drug Administration.” While device makers “will still have to quickly report any injuries or deaths related to their products,” they would have more time “to file reports on devices that may not be working properly, and have the potential for injury.” The deal, which is scheduled for a vote in the House on Wednesday, requires the FDA “to speed medical devices onto the market – and into patients – faster than ever.” One of the bill’s provisions “says the agency should permit companies to report malfunctions every three months, rather than the current practice of submitting reports within 30 days of a problem.”



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