A2LA is now recognized by the U.S. FDA as one of the first U.S. Accreditation Bodies approved to perform Biocompatibility Testing Laboratory Assessments under the FDA ASCA Pilot Program. This program applies FDA medical device guidance to biocompatibility testing methods.
For information on A2LA’s FDA recognized status and current scope of ASCA Recognition see ASCA – Recognized Accreditation Bodies. For consensus standards eligible for accreditation under the ASCA pilot Program see The FDA Recognized Consensus Standards Database.
A2LA’s FDA ASCA Biocompatibility Testing Laboratory Accreditation Program encompasses laboratories performing both in-vitro and in-vivo biocompatibility testing of medical devices. This program is one half of the FDA ASCA Pilot Program. The program page for Basic Safety and Essential Performance of Medical Devices can be found here, but you can contact us directly for more information.
This specialty program is covered by the A2LA biological field of testing.
- ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
- A2LA R256 – Specific Requirements – FDA ASCA Program
- Program guidance: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program – Final Guidance
- Biocompatibility standards-specific guidance: Biocompatibility Testing of Medical Devices- Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program