Lawmakers Ask FDA for Greater Transparency of 510(k) Safety Data

If the FDA follows the recommendations of two Democratic lawmakers, 510(k) databases could soon include more information about recalls and other safety problems. Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) sent a letter to CDRH Director Jeffrey Shuren detailing their concerns about the safety of devices cleared through the 510(k) process.
Devices & Diagnostics Letter