Under the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, the FDA grants ASCA Recognition to qualified accreditation bodies to accredit testing laboratories to perform premarket testing for medical device companies. ASCA-recognized accreditation bodies in turn accredit testing laboratories to ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories and the ASCA program specifications associated with each eligible FDA-recognized consensus standard and test method.
For more information, refer to the standards-specific ASCA Pilot guidance documents under “Guidances” on Accreditation Scheme for Conformity Assessment (ASCA) page.
On this page:
- How to Apply for ASCA Recognition
- FDA Review of Accreditation Body Applications
- FDA Engagement with ASCA-Recognized Accreditation Bodies
- Contact FDA
Accreditation bodies may apply to participate in the ASCA Pilot by sending an email to ASCA@fda.hhs.gov with attached documentation demonstrating that the applicant organization:
- Has 'signatory status' to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement
- Is based in the United States
- Has agreed to terms of participation described in Section D of Appendix A in the ASCA Pilot program guidance
Appendix A of the ASCA Pilot program guidance offers more information on application contents for accreditation bodies. In addition, accreditation bodies may submit a "Request for Clarification" to ASCA@fda.hhs.gov to ask questions about the ASCA Pilot.
The FDA intends to review applications for ASCA Recognition within 60 calendar days and notify the accreditation body via email of any issues that may preclude ASCA Recognition so that they may be addressed. When review is complete, the FDA will inform the accreditation body via email of the decision. If ASCA Recognition is granted, the FDA will provide a scope of ASCA Recognition and an expiration date.
List of Accreditation Bodies in the ASCA Pilot: When the FDA grants ASCA Recognition to an accreditation body, it will update the ASCA-recognized Accreditation Bodies list to reflect the organization's name, its scope of ASCA Recognition, and expiration date.
Number of Accreditation Bodies: There is no limit to the number of accreditation bodies who may receive ASCA Recognition.
Expiration: At the time ASCA Recognition is granted to an accreditation body, the FDA provides an expiration date for ASCA Recognition.
The FDA uses a variety of mechanisms to work with ASCA-recognized accreditation bodies to ensure they are adequately fulfilling program expectations. ASCA-recognized accreditation bodies:
- Attend FDA training
- Participate in regular teleconferences with the FDA
- Submit annual reports
- Are periodically audited by the FDA
Audits: The FDA intends to use a tiered, risk-based approach with three levels of audits.
- For Level 1 audits of an accreditation body, the FDA intends to leverage the existing arrangement of ILAC evaluations by requesting a copy of the most recent re-evaluation report.
- For Level 2 audits of the accreditation body, the FDA intends to participate as an observer during the next scheduled ILAC peer re-evaluation and request a copy of the re-evaluation report for review.
- For Level 3 audits, the FDA intends to initiate an on-site or remote audit of an accreditation body.
- For additional information related to audits, please refer to the ASCA Pilot program guidance.
After reading this page, the Accreditation Scheme for Conformity Assessment (ASCA) page, and the relevant guidances, if you have additional questions, email ASCA@fda.hhs.gov. You may also use this email address to submit documents associated with ASCA Recognition applications and maintenance, as well as to report issues.