FDA Names Accredited Laboratories for ASCA Pilot Program

The FDA has released a list of 53 accredited laboratories under its Accreditation Scheme for Conformity Assessment (ASCA) pilot program.

Testing labs that want to participate in the ASCA pilot should demonstrate that they have been accredited by an ASCA-recognized accreditation body under the currently FDA-recognized versions of the standards and test methods included in the ASCA pilot, the agency said.

Device manufacturers may choose an ASCA-accredited testing laboratory for premarket submission testing and can then include a declaration of conformity with any necessary supplemental documentation, such as an ASCA summary test report, as part of their premarket submission.