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

