USA – CDRH plans full ASCA pilot implementation, for 2021

A pilot conformity assessment program will be ready for full launch in 2021, according to a report by the US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH).
 
The report reviews the agency’s activities over the past year that supported full implementation of the Accreditation Scheme for Conformity Assessment (ASCA). Chief among these was the September 2020 publication of three final guidance documents that form the framework for the voluntary program. (RELATED: FDA finalizes ASCA pilot guidance as it gears up for launch, Regulatory Focus 24 September 2020; FDA discusses standards accreditation pilot ahead of launchRegulatory Focus 5 February 2020).\
 
The pilot implementation plan was launched following the publication of the trio of guidances. “At that time, ASCA staff immediately began to engage with accreditation bodies and testing laboratories to describe the ASCA Pilot and roles and responsibilities,” according to the report. A group of accreditation bodies who indicated interest and completed applications were included in an initial list of ASCA-recognized bodies…