On Wednesday, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) sent a letter asking FDA to overhaul two databases that provide public information about medical device safety, Health Data Management reports (Goedert, Health Data Management, 8/15).
The letter primarily focused on FDA's 510(k) Premarket Notification database but also mentioned the agency's recalls database (Markey/Merkley letter, 8/15).
The letter asked FDA about its willingness to:
- Update the 510(k) database to clearly indicate which devices had been recalled for flaws that could affect their safety or effectiveness;
- Update the 510(k) database within 30 days after reviewing a manufacturer's analysis that determined that a flaw leading to a medical device recall was serious; and
- Revise the 510(k) database to indicate when a device repeats a design flaw that caused a recall for a previous device (Health Data Management, 8/15).
The lawmakers asked FDA to respond to their questions by Sept. 19 (Markey/Merkley letter, 8/15).