The FDA hosted a webinar in October in conjunction with release of the final guidance discussing the appropriate use and documentation of consensus standards in submissions as well as how the agency intends to rely on them during review. Consensus standards (also known as voluntary consensus standards) are guidelines produced by national or international standards organizations (for example, the National Institute of Standards and Technology [NIST] or the International Standards Organization [ISO]) that provide a framework for testing or assessment of a product or process. Such standards often streamline applications for approval, confirm the quality of product released to the market, and simplify planning for new products. Standards can also enhance interoperability of products from different suppliers – for example, standards for CDs and DVD enable the availability of both media and players from many different manufacturers.

The FDA, consistent with the requirements of the 21st Century Cures Act, may choose to recognize any particular consensus standard. Once a standard has been recognized, it may be used in any pre-market submission, including INDs and BLAs. Conformity to one or more of these recognized consensus standards is unlikely to satisfy all requirements for the submission, but it can be an effective part of those requirements. They are not mandatory for devices unless the standard has been incorporated by reference into a regulation. Recognized standards are published in a web database on the FDA site and in the Federal Register.

Per the guidance, consensus standards may be included in a submission in only two ways

1. Using a Declaration of Conformity (DOC)
2. Through general use, without a DOC

The webinar was planned to help viewers understand

• Whether to elect to use a DOC,
• What to provide if you elect a DOC
• What to provide if you choose to use a standard without a DOC

A few other points are clarified in the webinar. You may not use a “promissory statement” (a statement saying the device will meet a conformance standard in the future) with a DOC because the FDA expects the device meets the standard prior to submission of the application. However, a promissory statement may be appropriate in some cases, and the device will have to meet the consensus standard before it is marketed. Also, changes to or withdrawal from recognition of an FDA-recognized consensus standard will not retroactively affect approved products. However, submissions for new devices citing that affected product cannot rely on a DOC to a changed or withdrawn standard. Check out the webinar page to view the presentation or read the slides and transcript.

There’s also a new draft guidance on the FDA’s process for recognition and withdrawal of voluntary consensus standards available for review and comment (see docket FDA-2018-D-2936-0001).

Text Copyright © 2018 Katrina Rogers