Lawmakers Ask FDA To Alter Device Safety Databases
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. The letter primarily focused on FDA's 510(k) Premarket Notification database but also mentioned the agency's recalls database. Among several queries, 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.
- "FDA Asked to Overhaul Medical Device Safety Databases" (Goedert, Health Data Management, 8/15).