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  5. Accreditation Scheme for Conformity Assessment (ASCA)
  1. Standards and Conformity Assessment Program

Accreditation Scheme for Conformity Assessment (ASCA)

The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) 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 ASCA Pilot is an accreditation scheme that capitalizes upon the increasingly prominent role that standards play in regulatory science and practice. 

The ASCA Pilot:

  • Potentially decreases the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories
  • Incorporates existing international conformity assessment standards and practices where practical
  • Was created using input from experts across the medical device manufacturing and standards conformity assessment communities

The voluntary ASCA Pilot is intended to enhance product reviewers' and device manufacturers' confidence in medical device testing, which should decrease the need for the FDA to request additional information regarding testing methodologies when a premarket submission includes ASCA Pilot testing. Ultimately, the ASCA Pilot 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 the ASCA Pilot in accordance with:

  • Amendments made to Section 514(d) of the Federal Food, Drug & Cosmetic Act by the FDA Reauthorization Act of 2017 (FDARA), and
  • The Medical Device User Fee Amendments of 2017 (MDUFA IV).

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

On this page:

Related pages:

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

ASCA Pilot: Key Facts

Participants: The ASCA Pilot 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 the ASCA Pilot.

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

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 documents and applications for the ASCA Pilot as well as to report issues.

How the ASCA Pilot Works

Under the ASCA Pilot, 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 the appropriate supplemental documentation (for example, 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 the ASCA Pilot 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 ASCA Pilot qualifications specified in the ASCA Pilot 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 Pilot specifications.
  4. After review of a testing laboratory's application, the FDA grants ASCA Accreditation to organizations who meet the ASCA Pilot qualifications specified in the ASCA Pilot program guidance.
  5. A device manufacturer may choose to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to the FDA.

Figure: Process flow for the ASCA Pilot

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 the ASCA Pilot

In accordance with the MDUFA IV commitment letter, the ASCA Pilot 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 Pilot 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 the ASCA Pilot.

Resources

Guidances

ASCA Pilot Workshop and Webinar Materials

The FDA hosted one workshop and two webinars on the ASCA Pilot. The materials (video presentation, printable slides, and transcript) are available on these pages:

Annual Reports

Training Modules

The FDA has 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.

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 Pilot 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 Pilot 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 the ASCA Pilot and is separate from any accreditation that an accreditation body may provide to a testing laboratory for purposes other than the ASCA Pilot.
  • 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 the ASCA Pilot entirely.
  • Withdrawing ASCA Recognition: Cancelling an accreditation body's full scope of ASCA Recognition; withdrawal of ASCA Recognition removes the organization from the ASCA Pilot entirely

 

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