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  5. Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot
  1. Standards and Conformity Assessment Program

Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot


ASCA Pilot Overview

What is the ASCA Pilot?

For an overview of information on the voluntary ASCA Pilot (for example, purpose, benefits, the standards currently identified for the pilot program) refer to the ASCA Web page.

For detailed information on the proposed goals and implementation of the ASCA Pilot, refer to the draft guidance entitled 'The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff.'

Whom do I contact with questions about the ASCA Pilot?

For questions regarding the ASCA Pilot that are not addressed on this Web page, on the ASCA Web page or in the draft guidance entitled "The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program," you may email ASCA@fda.hhs.gov.


Accreditation Bodies (ABs)

Would the FDA "certify" or "approve" accreditation bodies?

The FDA is not proposing to "certify" or "approve" accreditation bodies; we propose to "recognize" them once they have demonstrated ASCA Pilot qualifications. For further information on proposed terminology, refer to the draft guidance (Section V.D.).

How long would it take for the FDA to recognize an accreditation body for participation in the ASCA Pilot?

The FDA is proposing once an accreditation body submits a complete application for recognition, the process to issue a decision should take no more than 60 days. For further information, refer to the draft guidance (Section VIII.B.).

Would accreditation body recognition expire?

The FDA is proposing that an expiration date would be provided for any recognition granted by the FDA to an accreditation body or testing laboratory. For further information, refer to the draft guidance (Section VIII.B.).

Would there be a list of accreditation bodies participating in the ASCA Pilot?

FDA is proposing to post a list of testing laboratories and accrediting bodies participating in the ASCA Pilot to the ASCA Web page once available.  ASCA Accreditation status for testing laboratories would also be provided on the Web page as well.


Testing Laboratories (TLs)

Would the FDA "certify" or "approve" testing laboratories?

The FDA is not proposing to "certify" or "approve" testing laboratories.  We propose to "recognize" them and subsequently grant "ASCA Accreditation" if they demonstrate Pilot qualifications. For further information on proposed terminology, refer to the draft guidance (Section V.D.).

Could international testing laboratories participate in the ASCA Pilot?

FDA is proposing to accept international testing laboratories as participants in the ASCA Pilot.

Would all recognized testing laboratories need to be Good Laboratory Practices (GLP) compliant?

The FDA is proposing testing laboratories be accredited for the ASCA Pilot using ISO/IEC 17025 and the ASCA program specifications. Several proposed ASCA program specifications for biocompatibility standards and test methods (provided in Appendix A of the draft guidance) address the need for GLP compliance. For example:

  • Testing laboratories should have policies and procedures in place to implement 21 CFR part 58, Good Laboratory Practice for Nonclinical Laboratory Studies (Appendix A, section 6.3); and
  • Test results should include a statement that testing was conducted according to 21 CFR part 58, Good Laboratory Practice for Nonclinical Laboratory Studies (Appendix A, section 7.8).

In addition, the accreditation body application (Appendix C of the draft guidance) would include a section for applicants to describe their approach to assessing procedures and corrective actions related to the most recent inspection findings noted by the FDA Bioresearch Monitoring Program, per 21 CFR part 58, Good Laboratory Practice for Nonclinical Laboratory Studies, for testing laboratory applicants with biological evaluation of medical device standards in their scope of recognition.

How much time would be required for a testing laboratory to become recognized and receive ASCA Accreditation?

The time needed for the prerequisite accreditation by individual accreditation bodies would vary and is not stipulated in the draft guidance. The FDA is proposing that once a testing laboratory is accredited by an FDA-recognized accreditation body and submits a complete application to the FDA, the FDA's proposed recognition and ASCA Accreditation steps should require no more than 60 days. For further information, refer to the draft guidance (Section VIII.B.).

Would recognition and ASCA Accreditation for testing laboratories expire?

The FDA is proposing that an expiration date would be provided for any recognition granted by the FDA to an accreditation body or testing laboratory. For further information, refer to the draft guidance (Section VIII.B.).

Would there be a list of testing laboratories participating in the ASCA Pilot?

FDA is proposing that, when available, a list of testing laboratories and accreditation bodies participating in the ASCA Pilot would be posted to the ASCA Web page. ASCA Accreditation status would also be provided for testing laboratories.


Manufacturers

Would manufacturers be required to apply to participate?

FDA is not proposing an application process for manufacturers to participate in the voluntary ASCA Pilot program.

What devices and premarket submissions would be eligible for the ASCA Pilot?

The FDA is proposing that testing performed by an ASCA-accredited testing laboratory may be used to support a premarket submission for any device if the testing was conducted using an ASCA-eligible standard and in accordance with the ASCA program specifications for that standard.

How would FDA's review of ASCA-accredited testing differ from its review of testing from testing laboratories outside the ASCA Pilot?

The proposed ASCA Pilot policies and processes are intended to provide confidence in accreditation body and testing laboratory activities. Thus, the FDA generally would accept ASCA-eligible standards testing results from ASCA-accredited testing laboratories without questioning the validity of test methods or reviewing complete test results except in the below circumstances:

  • As part of a periodic audit; or
  • If the summary test report indicates an issue with the testing or device; or
  • If the FDA becomes aware of information materially bearing on the safety or effectiveness of the device.

For further information, refer to the draft guidance (Section III).

Would the device manufacturer or the testing laboratory send the test results to FDA?

As proposed, the device manufacturer would be responsible for providing all relevant information in the premarket submission. This includes documenting how testing supports approval or clearance, even when such testing is performed by an ASCA-accredited testing laboratory.

For further information, refer to the draft guidance, which proposes example ASCA summary test reports (Appendices E and F) and recommended contents for premarket submissions with testing from an ASCA-accredited testing laboratory (Section VIII.B.).

Could a device manufacturer's in-house testing laboratory participate in the ASCA Pilot? 

FDA is proposing to accept in-house testing laboratories as participants in the ASCA Pilot. For further information, refer to the draft guidance (Section V.A.).