Accreditation Bodies: How to Participate in ASCA
Update: September 20, 2024
On September 20, 2024, the FDA issued the following draft guidances:
- The Accreditation Scheme for Conformity Assessment (ASCA) Program
- Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program
- Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program
These guidances include updates to the ASCA program based on feedback from public meetings, webinars, stakeholder meetings, and lessons learned internally during the pilot phase.
When final, these guidances will replace the three ASCA Pilot guidances published September 25, 2020.
Under the voluntary Accreditation Scheme for Conformity Assessment (ASCA) Program, 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 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 guidance documents under “Guidances” on the 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
- Maintaining ASCA Recognition Status
- Contact FDA
Related pages:
| Participant | Pages |
|---|---|
| Testing laboratories |
List of ASCA-Accredited Testing Laboratories |
| Manufacturers | |
| All participants |
Accreditation Scheme for Conformity Assessment (ASCA) |
How to Apply for ASCA Recognition
Accreditation bodies eligible to receive ASCA Recognition may apply to participate in the ASCA Program 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 Program guidance
Application contents should reflect the following:
- Administrative information, including the designated points of contact
- The requested scope of ASCA Recognition (see the list of standards included in ASCA);
- Information in support of competence. See Section C of Appendix A in the ASCA Program guidance for details.
- A signed agreement noting that the applicant agrees to adhere to the terms outlined in Section D of Appendix A in the ASCA program guidance.
Appendix A of the ASCA Program guidance offers more information on application contents for accreditation bodies.
FDA Review of Accreditation Body Applications
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 Program: 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.
FDA Engagement with ASCA-recognized Accreditation Bodies
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:
- Provide notification to the FDA within five calendar days by email of any changes that may impact the accreditation body’s participation or of any changes that may impact the participation of any of the testing laboratories the accreditation body has accredited
- Attend FDA training
- Participate in regular teleconferences with the FDA
- Submit annual reports as outlined in the ASCA Program guidance
- 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 Program guidance.
Maintaining ASCA Recognition Status
Expiration: At the time ASCA Recognition is granted to an accreditation body, the FDA provides an expiration date for ASCA Recognition.
Contact the FDA
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.