The Accreditation Scheme for Conformity Assessment (ASCA) Pilot is intended to help the FDA ensure that patients have timely and continual access to safe, effective, and high-quality medical devices. ASCA Accreditation is a status granted by the FDA to testing laboratories that demonstrate competence in testing via the application process described in the ASCA Pilot program guidance.
How does the FDA's ASCA Pilot Program work?
The FDA grants ASCA Accreditation to qualified testing laboratories, relying on international conformity assessment standards and a set of FDA-identified ASCA program specifications.
The steps in the ASCA Pilot are:
- Accreditation bodies may apply to the FDA for ASCA Recognition.
- After reviewing an accreditation body's application, the FDA grants ASCA Recognition to organizations who meet the ASCA Pilot qualifications specified in the ASCA Pilot program guidance.
- Testing laboratories may apply to the FDA for ASCA Accreditation in a two-step process that begins with an assessment by an ASCA-recognized accreditation body to ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories and the additional ASCA Pilot specifications.
- After review of a testing laboratory's application, the FDA grants ASCA Accreditation to organizations who meet the ASCA Pilot qualifications specified in the ASCA Pilot program guidance.
- A device manufacturer may choose to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to the FDA.