FDA Urges Caution, Use Of ASCA To Stem Faulty Data In Device Submissions

FDA is strongly urging device makers to use accredited third parties recognized by the agency to ensure their pre-market submissions don’t include falsified test results, pointing to growing concerns that fabricated data from unaccredited third parties in China and India are showing up in device applications. FDA is considering expanding its third-party Accreditation Scheme for Conformity Assessment (ASCA) to address the problem, the agency’s device chief said this week. FDA plans to hold a virtual public workshop April 17 to...