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GUIDANCE DOCUMENT

The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff September 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-3805


Docket Number:
FDA-2019-D-3805
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The Pilot Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Pilot) is authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).1 In accordance with amendments made to section 514 by the FDA Reauthorization Act of 2017 (FDARA),2 and as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV),3 FDA was directed to issue a draft guidance regarding the goals and implementation of the ASCA Pilot.4 The establishment of the goals, scope, procedures, and a suitable framework for the voluntary ASCA Pilot supports the Agency's continued efforts to use its scientific resources effectively and efficiently to protect and promote public health. FDA believes the voluntary ASCA Pilot may further encourage international harmonization of medical device regulation because it incorporates elements, where appropriate, from a well-established set of international conformity assessment practices and standards (e.g., ISO/IEC 17000 series). The voluntary ASCA Pilot does not supplant or alter any other existing statutory or regulatory requirements governing the decision-making process for premarket submissions.

This draft guidance refers to voluntary consensus standards.5 For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of standards in regulatory submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices and Standards Development and the Use of Standards in Regulatory Submission Reviewed in CBER.

1 21 U.S.C. 360d(d)

2 SeePub. L. 115-52

3 See also MDUFA IV Commitment Letter

4 See section 514(d)(3)(B)

5 For the purposes of this guidance, the term 'standard' or 'standards' will be used to refer to 'consensus standard' or 'consensus standards'.