Medical Device Makers may Delay Reporting of Injury and Death
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 F.D.A. and the $148 billion device industry. Renegotiated every five years, the agreement includes the fees that device makers must pay for the agency to review their products. It is scheduled for a vote in the House of Representatives on Wednesday.
The current draft compels the F.D.A. to speed medical devices onto the market — and into patients — faster than ever. But, at a time when the F.D.A. acknowledges that medical device mishaps are vastly underreported, a provision in the bill 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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