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GUIDANCE DOCUMENT

Recognition and Withdrawal of Voluntary Consensus Standards Guidance for Industry and Food and Drug Administration Staff September 2018

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2018-D-2936
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The Food and Drug Administration (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. The guidance outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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-2018-D-2936.