Evidence that CDRH may be ignoring the “least burdensome” provision outlined in federal statutes has led to an inquiry into the agency by the House Energy and Commerce Committee. “It has come to the committee’s attention that the FDA may be actively thwarting the mandates of Congress and fostering regulatory uncertainty and unnecessary delays by reducing its use of the least burdensome provisions,” lawmakers say in a letter sent to CDRH Director Jeffrey Shuren.
Devices & Diagnostics Letter