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  5. Accreditation Scheme for Conformity Assessment (ASCA)
  1. Device Advice: Comprehensive Regulatory Assistance

Accreditation Scheme for Conformity Assessment (ASCA)

Accreditation Scheme for Conformity Assessment (ASCA)

The Accreditation Scheme for Conformity Assessment (ASCA) will be piloted under the auspices of CDRH's Standards and Conformity Assessment Program. The ASCA Pilot Program aims to enhance the predictability of the medical device review process by reducing premarket questions in areas where current conformity activities result in inconsistent testing practices, conformance declarations, and regulatory review. ASCA is intended to increase the consistency of submissions, saving FDA resources in the review of certain testing.

The ASCA Pilot Program will also promote the development and recognition of consensus standards and improve post market safety and performance evaluation due to a greater understanding of how the device was tested and evaluated.

As our Medical Device User Fee Amendments (MDUFA IV) commitment letter states, the pilot will ensure appropriate interaction between FDA, accreditation bodies, and testing labs.

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How is FDA developing the ASCA Pilot Program?

ASCA emerged from discussions with device manufacturers during negotiations for MDUFA IV and was included in section 514(d) of the FD&C Act. Participants agreed that this approach has the potential to significantly promote the use of consensus standards, reduce burden on manufacturers, and enhance conformity assessment processes.  

In our efforts to begin to establish the framework, procedures and requirements of the ASCA Pilot Program, and as part of our MDUFA IV commitments, FDA has solicited input through a Federal Register notice (May 2017), a public workshop (May 2018), and many other discussions and outreach opportunities. FDA continues to develop the ASCA Pilot Program scheme and stakeholders will have additional opportunities to provide suggestions. In particular, we plan to publish the draft guidance by the end of fiscal year 2019 and will request comments when we publish the draft. The guidance will include more specific information about participation in and operation of the ASCA Pilot Program.

Why is the FDA implementing the ASCA pilot program?

ASCA capitalizes on the relevance of consensus standards in device development and regulatory review. FDA and industry agreed during MDUFA IV negotiations that an accreditation program has the potential to improve device premarket review, especially standards conformity assessment activities. We intend to establish the ASCA Pilot Program to fulfill our MDUFA IV commitment and the corresponding statutory requirements added by section 205 of the FDA Reauthorization Act of 2017.

What may be the benefits of ASCA?

The ASCA Pilot Program is intended to minimize the need to submit complete test reports and reduce the number of additional information requests.

How do we envision the ASCA Pilot Program working?

Under the ASCA Pilot Program, FDA will define a conformity assessment scheme describing the interactions between and specifications for accreditation bodies and testing labs. Analogous to other types of third party accreditations, the scheme will outline a process for participation by accreditation bodies and testing labs and the suspension or withdrawal of poorly performing participants. In order to promote transparency, we intend to publicly post information on FDA’s Web site about ASCA testing labs, including the FDA-recognized consensus standards for which they are accredited.

Which standards are likely to be included in the ASCA Pilot Program?

FDA is still determining the standards to be included in the ASCA Pilot Program. As noted above, FDA has consulted with stakeholders as part of this process and identified a potential series of standards for initial consideration. Per our MDUFA IV commitment, the Pilot Program will include a minimum of five appropriate FDA-recognized consensus standards, at least one of which will be device-specific. During the public workshop, presentations and discussions focused on standards from the following areas:

  • Biological evaluation of medical devices
  • Basic safety and essential performance of medical electrical equipment, medical electrical systems and laboratory equipment

We will announce the standards which are part of the ACSA Pilot Program at a future date.

Are there plans to expand the number of standards included in the ASCA Pilot Program?

Expanding the standards included in the ASCA Pilot Program will depend on several factors. FDA intends to provide annual reports on the progress of the ASCA Pilot Program and work with stakeholders to identify improvements, including consideration for expansion. Under section 514(d)(4) of the FD&C Act, the program will sunset October 1, 2022; however, if the pilot establishes the utility of the program, it may become permanent. We would expect to add more standards if and when the ASCA Pilot Program becomes permanent.

When do we envision the ASCA Pilot Program will launch?

In accordance with section 514(d)(3)(C) of the FD&C Act, FDA must initiate the ASCA Pilot Program no later than September 30, 2020, but we are working to do so as soon as possible and before that date.

Whom do I contact if I have a question about ASCA?

Please send an email to ASCA@fda.hhs.gov

For general regulatory information, contact the Division of Industry and Consumer Education (DICE) by phone at (800) 638-2041 or (301) 796-7100 or by email at DICE@fda.hhs.gov.