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FDA Asked to Overhaul Medical Device Safety Databases

Published
  • August 15 2012, 12:11pm EDT

Two members of Congress are calling on the Food and Drug Administration to overhaul databases providing public information about the safety of medical devices that rarely undergo clinical trials.

Legislation introduced in February, H.R. 3847, would permit FDA to reject an application for a new device if it is modeled after an earlier product that was pulled from the market after causing harm. The bill remains pending in the House of Representatives.

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