FDA ASCA Program: What Manufacturers Need to Know About Accredited Testing Laboratories

By /

Under the Accreditation Scheme for Conformity Assessment (ASCA), the U.S. FDA accepts test results from accredited laboratories for selected consensus standards with fewer additional questions during premarket review. To use an ASCA report effectively, manufacturers need to understand how the scheme is structured.

How the ASCA scheme works

  • The FDA does not accredit testing laboratories directly. It first recognises accreditation bodies (ABs) that meet strict requirements.
  • FDA-recognised ABs then assess testing laboratories against ISO/IEC 17025:2017 and the ASCA-specific program requirements and grant ASCA accreditation.
  • Only reports from laboratories holding ASCA accreditation issued by an FDA-recognised AB benefit from the FDA’s streamlined acceptance.

Official FDA databases

Points to check before relying on an ASCA report

  • The status of the AB directly affects the report: if the FDA withdraws recognition of an AB, the ASCA accreditation of all laboratories it accredited lapses as well, and their reports are no longer accepted under ASCA.
  • ABs have limited scopes: each AB is recognised for specific ASCA areas. For example, NVLAP currently does not cover biocompatibility testing.
  • Non-recognised ABs do not count: even internationally renowned accreditation bodies (such as UKAS in the United Kingdom) do not confer ASCA status unless they are on the FDA’s list of ASCA-recognised ABs.
  • ASCA must be explicitly in scope: confirm that the laboratory’s accreditation scope expressly includes the ASCA requirements, not just a general ISO/IEC 17025 accreditation.
  • Accreditation is standard-specific: ASCA accreditation is granted standard by standard. A laboratory may be ASCA-accredited for IEC 60601-1 (electrical safety) but not for IEC 60601-1-2 (EMC).
  • Standard versions must match: check that the version of the standard used for testing is the version currently recognised by the FDA.

How EVERBIZ can help

EVERBIZ supports manufacturers with FDA submissions, test planning and the selection of suitable ASCA-accredited laboratories. Contact us if you would like us to review your test strategy.

This article is for general information only and does not constitute legal advice. The official FDA documents are authoritative.

Scroll to Top