FDA to propose guidelines on med device reports—NYT
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The Food and Drug Administration will soon propose guidelines meant to make the annual safety reports filed by manufacturers of medical devices more complete and more accessible to the public, The New York Times reported on Saturday.
Dr. Daniel Schultz, the director of the FDA’S Center for Devices and Radiological Health, told the newspaper that the changes were part of a wider effort to improve the agency’s monitoring of medical devices after they are approved for sale.
“There are a lot of things we are doing,” Schultz told the newspaper, “but there are still some things that fall through the cracks.”
Schultz said the new guidelines, which the Times said were expected to be announced in the coming months, would make data reported by manufacturers both more useful to the agency and more available to the public.
While the Times said Schultz did not provide details, it said that because the reports contain some trade secrets, the guidelines might require manufacturers to segregate safety information from trade data in their filings.
“We are going to try to fix some of those difficulties,” so safety data can be made public, the newspaper quoted Schultz as saying.
The FDA regulates medical products like surgical tools, artificial hips, diagnostic equipment and heart defibrillators. Defibrillators manufactured by Guidant Corp. were recalled after the FDA found that electrical flaws could create a “reasonable likelihood of serious injury or death.”
Schultz also told the Times that a separate FDA task force formed in September to review and improve the agency oversight of defibrillator and pacemaker safety is expected to release its recommendations this spring.
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