www.fdanews.com/articles/148895-lawmakers-ask-fda-for-greater-transparency-of-510-k-safety-data
Lawmakers Ask FDA for Greater Transparency of 510(k) Safety Data
August 23, 2012
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
Devices & Diagnostics Letter