USA – FDA finalizes ASCA pilot guidance as it gears up for launch

The US Food and Drug Administration (FDA) on Thursday issued three final guidances on its Accreditation Scheme for Conformity Assessment (ASCA) pilot program.
 
The program, which arose out of the negotiations for the current Medical Device User Fee Amendments (MDUFA IV), is meant to increase “consistency, predictability and efficiency” during the premarket review of medical devices by creating a scheme for accrediting third party testing laboratories to eligible consensus standards.
 
Device makers will then be able to use testing performed by accredited labs to support premarket submissions to FDA. (RELATED: FDA details long-awaited standards accreditation pilot in new draft guidanceRegulatory FocusRegulatory Focus 23 September 2019; FDA discusses standards accreditation pilot ahead of launchRegulatory Focus 5 February 2020)…