USA – FDA issues progress report for ASCA medical device conformity assessment pilot

A new report from the US Food and Drug Administration on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program explains the agency’s progress thus far as well as ongoing implementation plans ahead of the program’s expected launch later in 2020.

The report lays out next steps FDA will undertake in order to formally establish the ASCA pilot this year. First proposed in 2017, the ASCA program is intended to improve consistency of FDA medical device premarket submissions by utilizing accredited testing laboratories to evaluate whether US market applicants’ declarations of conformity to voluntary consensus standards such as ISO 10933-4 for biological evaluation of devices and ANSI/AAMI 60601-1 for safety and performance of medical electrical devices. The report follows draft guidance FDA issued in September 2019…