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  7. Accreditation Scheme for Conformity Assessment (ASCA)
  1. Division of Standards and Conformity Assessment

Accreditation Scheme for Conformity Assessment (ASCA)

Update: September 20, 2024

On September 20, 2024, the FDA issued the following draft guidances:

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.

The Center for Devices and Radiological Health's (CDRH) Division of Standards and Conformity Assessment (DSCA) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions, as conformity to relevant standards both reduces regulatory burden and fosters quality. 

The voluntary ASCA Program is an accreditation scheme that capitalizes upon the increasingly prominent role that standards play in regulatory science and practice. ASCA's goals are to:

  • Streamline conformity assessment in device submissions
  • Enhance the FDA’s confidence in test methods and results
  • Decrease the need for additional information related to conformance with a standard
  • Promote consistency, predictability, and efficiency in medical device review
  • Serve as a least burdensome approach to conformity assessment

Ultimately, ASCA is intended to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.

The FDA is implementing ASCA in accordance with:

  • Amendments made to Section 514(d) of the Federal Food, Drug & Cosmetic Act by the Food and Drug Omnibus Reform Act of 2022, and
  • The Medical Device User Fee Amendments of 2022 (MDUFA V).

If you would like to receive notifications about ASCA, email ASCA@fda.hhs.gov.

On this page:

Related pages:

Participants Pages
Accreditation bodies List of ASCA-Recognized Accreditation Bodies 
Accreditation Bodies: How to Participate in ASCA 
Testing laboratories List of ASCA-Accredited Testing Laboratories
Testing Laboratories: How to Participate in ASCA
Manufacturers Manufacturers: How to Participate in ASCA 
All participants Recognized Consensus Standards Included in ASCA 

Voluntary ASCA Program: Key Facts

Participants: ASCA includes participation from accreditation bodies, testing laboratories, device manufacturers and FDA staff.

Fee for participation for accreditation bodies and testing laboratories: The FDA does not charge a fee for accreditation bodies or testing laboratories to participate in ASCA.

Fee for participation for manufacturers:  ASCA is funded through the MDUFA V User Fee program. The FDA does not charge an additional fee for manufacturers to participate in ASCA.

FDA communications with ASCA stakeholders: The FDA routinely meets with stakeholders participating in ASCA. The FDA does not communicate with ASCA-recognized accreditation bodies or ASCA-accredited testing laboratories about test reports in specific premarket submissions without consulting with the sponsor.

Final Guidances (September 25, 2020)

Contact: After reading this page and the guidances, if you have additional questions, email ASCA@fda.hhs.gov. You may also use this email address to submit ASCA-related documents and applications as well as to report issues.

How ASCA Works

Under the ASCA program, the FDA grants ASCA Recognition to qualified accreditation bodies to accredit testing laboratories to perform premarket testing for medical device companies. The FDA grants ASCA Accreditation to qualified testing laboratories, relying on international conformity assessment standards and a set of FDA-identified ASCA program specifications. 

A device manufacturer may choose to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to the FDA. For such testing, ASCA-accredited testing laboratories provide the device manufacturer with all the information listed in the relevant ASCA program specifications. When the device manufacturer includes a declaration of conformity with an ASCA Summary Test Report as part of their premarket submission, the FDA will have confidence in the testing laboratories’ test methods and results and does not intend to request additional information regarding testing methodologies.

The steps in ASCA program are:

  1. Accreditation bodies may apply to the FDA for ASCA Recognition.
  2. After review of an accreditation body's application, the FDA grants ASCA Recognition to organizations who meet the qualifications specified in the ASCA program guidance.
  3. 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 specifications.
  4. After review of a testing laboratory's application, the FDA grants ASCA Accreditation to organizations who meet the ASCA qualifications specified in the ASCA program guidance.
  5. A device manufacturer may choose to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to the FDA.

The 2018 guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices provides additional helpful information about declarations of conformity and their important role in regulatory review.

Standards Included in ASCA

The ASCA program includes both cross-cutting (horizontal) and device-specific (vertical) standards, which are of public health significance and have or are able to provide the means for establishing acceptance criteria.

Based upon input from the medical device community, the FDA chose standards and tests from the biocompatibility and basic safety and essential performance series.

View ASCA Standards

Manufacturers should continue to rely on other FDA-recognized standards and provide declarations of conformity in premarket submissions (see Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices); however, other standards will not be eligible for the benefits of ASCA.

Resources

Guidances

ASCA Training

The FDA hosted several ASCA-related educational events during the pilot phase. The materials (video presentation, printable slides, and transcript) are available on these pages:

The FDA developed CDRH Learn modules on standards, each of which includes the recorded presentation, printable slides, and transcript.

To access the modules:

  • Go to CDRH Learn.
  • Click How to Study and Market Your Device.
  • Scroll down to Standards.

Annual Reports

Other Resources

Historical information on the ASCA program is available in the FDA Archive.

Terminology

  • Standards recognition: The process whereby the FDA identifies standards to which manufacturers of medical devices may submit a declaration of conformity to demonstrate they have met relevant requirements in the FD&C Act.
  • ASCA Recognition: A status granted by the FDA to accreditation bodies that demonstrate competence in accreditation activities via the application process described in the ASCA program guidance. ASCA-recognized accreditation bodies may accredit qualified testing laboratories if the FDA-recognized consensus standards and test methods were within their scope of ASCA Recognition at the time of accreditation.
  • Accreditation: Third-party attestation in which a conformity assessment body (e.g., a testing laboratory) has formally demonstrated its competence to carry out specific conformity assessment tasks (see ISO/IEC 17000:2004 Conformity assessment - Vocabulary and general principles).
  • ASCA Accreditation: A status granted by the FDA to testing laboratories that demonstrate competence in testing via the application process described in the ASCA program guidance. One of the qualifications for ASCA Accreditation is that a testing laboratory have a scope of accreditation from an ASCA-recognized accreditation body. Note that ASCA Accreditation exists only within ASCA and is separate from any accreditation that an accreditation body may provide to a testing laboratory for purposes other than ASCA.
  • Suspension of ASCA Accreditation: Putting temporary constraints in place for one or more FDA-recognized consensus standards or test methods within a testing laboratory's scope of ASCA Accreditation.
  • Withdrawing ASCA Accreditation: Cancelling a testing laboratory's full scope of ASCA Accreditation; withdrawal of ASCA Accreditation removes the organization from ASCA entirely.
  • Withdrawing ASCA Recognition: Cancelling an accreditation body's full scope of ASCA Recognition; withdrawal of ASCA Recognition removes the organization from ASCA entirely.

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