FDA deal would relax rules on reporting medical device problems


Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress. Device makers will still have to quickly report any injuries or deaths related to their products.

They would have more time, though, to file reports on devices that may not be working properly, and have the potential for injury. The deal is part of a pact between the FDA and the $148-billion device.

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