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  7. Accreditation Bodies: How to Participate in ASCA
  1. Division of Standards and Conformity Assessment

Accreditation Bodies: How to Participate in ASCA

Update: September 18, 2025

The FDA has updated the “ASCA-Accredited Testing Laboratories” database to note the withdrawal of ASCA Accreditation for certain laboratories. These laboratories are listed as having an “FDA Initiated Withdrawal” status in the ASCA-accredited Testing Laboratory database. ASCA Summary Test Reports from laboratories with an “FDA Initiated Withdrawal” status will no longer be accepted.

During audits of ASCA-accredited testing laboratories, the FDA determined that the labs did not meet the requirements outlined in Section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related ASCA Program guidance(s). In some cases, the FDA identified concerns about the integrity of the data the labs submitted in premarket submissions. These findings raised serious questions about the ability of certain laboratories to fulfill their role in the FDA’s ASCA Program.

The FDA remains committed to maintaining the integrity of the ASCA Program and will continue to update the list of ASCA-accredited testing laboratories, as necessary. 

Update: July 28, 2025

DSCA has fully recognized IEC 61326-2-6 Edition 4 (Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment). This standard is part of the family of standards under IEC 61010 and within the scope of the ASCA Basic Safety and Essential Performance standards-specific guidance. This new edition is the result of active collaboration between CDRH and industry and greatly expands the ability of IVD device manufacturers to take advantage of the ASCA Program.

On this page:

Related pages:

ParticipantPages
Testing laboratoriesList of ASCA-Accredited Testing Laboratories
Testing Laboratories: How to Participate in ASCA
ManufacturersManufacturers: How to Participate in ASCA 
All participantsAccreditation Scheme for Conformity Assessment (ASCA)
Recognized Consensus Standards Included in 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:

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.

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