The FDA has been criticized for approving medical devices through the 510K (fast track) approval requiring no clinical trials. But there’s another way-read on.
U.S. Rep. Ed Markey and U.S. Sen. Jeff Merkley write a letter to FDA asking them to update the 510(k) medical device database to provide better information about devices recalled for serious design flaws and to help avoid future injuries.
In an effort to make the data concerning medical devices more available to the public, Representative Edward Markey (D-Massachusetts) and Senator Jeff Merkley (D-Oregon) have sent a letter to the FDA. In the letter, they ask about the FDA’s willingness to make changes to the 510(k) premarket notification database. The lawmakers requested answers to their questions by September 19, 2012.
The intent of our Twitter chat on May 17 was to debunk industry claims about the FDA’s device approval process and explain what consumers really need to know about the medical device user fee bills.