Recognition and Withdrawal of Voluntary Consensus Standards

On 14 September 2020 the FDA announced the availability of the final guidance for industry and FDA staff.

The FDA developed this document to provide guidance to industry and FDA staff about the procedures the Center for Devices and Radiological Health (CDRH) follows when we receive a request for recognition of a voluntary consensus standard for medical products. The guidance outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard.

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