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Medical Device CRO Blog

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DANGER! Another Loophole in 510(k)

  
  
  

Rep. Edward Markey, D-Mass., and Sen. Jeff Merkley, D-Ore., are pressing FDA to make it clear 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.

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