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."
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.