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Compliance In Focus
Posted by John Lehmann on Wed, Aug 29, 2012

DANGER! Another Loophole in 510(k)

Rep. Edward Markey, D-Mass., and Sen. Jeff Merkley, D-Ore., are pressing FDA to make it clearDanger 510k on the public 510(k) when a device has been the subject of a recall due to a serious design flaw.  In a letter the legislators build their case why increasing transparency in federal databases would help prevent flawed medical devices from coming to market, and hopefully help prevent serious patient injury.

Earlier this summer law makers failed to close loopholes that allowed devices to be approved if they even if a previous device of a similar model was recalled for a major safety defect.  This loophole has allowed a number of dangerous and defective devices– such as the bladder mesh implants – to go to market.

According to the press-release, in the letter the representatives as for responses to questions like:

  • Is the FDA willing to update its 510(k) database so that it clearly indicates devices that have been recalled for serious design flaws that could adversely affect safety or effectiveness?
  • Will the FDA update the database within 30 days after completing its review of a manufacturer’s root-cause analysis that concludes that a flaw triggering the recall was a serious one that could adversely affect safety or effectiveness?
  • Will the FDA include in the database past recalls clearly marked for serious design flaws that could adversely affect safety or effectiveness, so device manufacturers and the public have comprehensive information about problematic predicates?
  • Is the FDA willing to revise its 510(k) Premarket Notification database to notify the public that a certain product repeats the same design flaw that caused a predicate’s recall?

Both Markey and Merkley acknowledge that in some cases it is appropriate to clear a device relying on a predicate device that has been recalled for safety reasons, if the issue has been corrected.  Their goal is to notify the public that a product has been allowed on the market when the problem has not been addressed.  They have asked for response to their letter by September 19th.

Is this a case of government over-reach?  Or do you support these legislators attempt to close the loopholes in the 510(k) program.  Share your thoughts with us.

Photo Credit: unlisted sightings

Topics: Rep. Edward Markey, Sen. Jeff Merkley, FDA, 510(k)

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