Under an agreement with the Food and Drug Administration that’s headed for a Congressional vote, manufacturers of medical devices—a $148 billion product category covering everything from insulin pumps to breast implants and cardiac defibrillators—could be allowed to report malfunctions of their products less frequently than they currently do.
While injuries or deaths related to their products still have to be promptly reported, new rules would allow medical device makers to report product malfunctions every three months instead of within 30 days of an issue occurring, the New York Times reports.
