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Guidance Issuing OfficeCenter for Devices and Radiological Health
The purpose of this document is to establish internal Center for Devices and Radiological Health (CDRH) procedures for the identification and evaluation of consensus standards for recognition through publication of a notice in the Federal Register. This document may be amended in the future to include modified or additional procedures.
The Food and Drug Administration Modernization Act (FDAMA) added section 514(c) to the Federal Food, Drug, and Cosmetic Act. This new provision states in part that FDA "shall, by publication in the Federal Register, recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under this Act to which a standard is applicable."
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:
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.