Call for FDA to overhaul medical device databases
Published date : 23 August 2012
Article date : 23 August 2012
2 members of Congress are calling on the DA to overhaul databases providing public information about the safety of medical devices that rarely undergo clinical trials. Legislation introduced in February would allow the FDA to reject an application for a new device if it is modeled on an earlier product that has been taken off the market after causing harm. The bill remains pending in the House of Representatives.
In the absence of legislation being enacted, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) have sent a letter to the FDA with several questions to assess the agency’s willingness to make certain changes, including:
* Updating the 510(k) database to indicate devices that have been recalled for design flaws that could affect safety or effectiveness
* Update the database within 30 days after completing a review of a manufacturer’s root-cause analysis that concludes a flaw triggering a recall was serious
* Include in the database clearly marked past recalls for serious design flaws that could affect safety or effectiveness
* Revise the 510(k) Premarket Notification database to notify the public that a certain product repeats the same design flaw that caused a predicate’s recall
Source: healthdatamanagement.com, 20 Aug 2012
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