FDA Says It Will Be More Aggressive In Warning About Possible Medical Device Risks

Originally published by Robert Kraft.

STAT reports that the Food and Drug Administration “said that it plans to take a far more aggressive stance in reporting on possible medical device hazards, in some cases issuing early warnings about safety risks even before those concerns have been validated.” In a draft guidance document (pdf), the FDA said it believed there is a “need to notify the public about emerging signals that the agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the agency does not yet have specific recommendations.” The move “follows several high-profile lawsuits involving safety risks and medical devices, as well as a string of warnings from the FDA about various products.”

From the news release of the American Association for Justice.

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