2019年 9月 24日
New guidance from the US Food and Drug Administration establishes a highly anticipated pilot program for voluntary conformity assessments to improve premarket reviews.
FDA’s draft Accreditation Scheme for Conformity Assessment (ASCA) pilot follows the agency’s mid-2017 proposal to utilize accredited testing laboratories to assess compliance of medical device registrants’ declarations of conformity to voluntary consensus standards. The ASCA would support more consistent evaluation of whether FDA premarket submissions meet these standards’ requirements. The pilot is slated for launch by September 30, 2020.
The ASCA pilot entails standards testing laboratories undergoing accreditation by recognized accreditation bodies; accredited laboratories then test medical devices to determine their conformance to at least one standard eligible for inclusion in the pilot.
Test results from an ASCA-accredited laboratory may then be used by a manufacturer to support a premarket submission to FDA for any device, according to the guidance.
“When such testing is submitted to FDA, the Agency generally will accept the testing laboratory’s determinations that a device conforms with the specified standards based on the increased confidence in the reliability of the testing laboratory’s determination provided by the ASCA pilot,” FDA states in the guidance.
By launching the pilot, FDA aims to boost consistency and predictability in its device premarket review processes as well as free up agency resources via greater reliance on ASCA-accredited laboratories for device testing.
In addition, the ASCA pilot is intended to improve regulatory efficiencies by reducing premarket review issues regarding device testing methodologies, as well as drive international regulatory harmonization by including primarily international consensus standards in the program.
FDA seeks participation from accreditation bodies, testing laboratories, medical device manufacturers as well as the agency’s own staff for the ASCA pilot.