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GUIDANCE DOCUMENT

FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act Guidance for Industry and Food and Drug Administration Staff April 2012

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The purpose of this guidance is to establish procedures for submitting, reviewing and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that are submitted in accordance with section 513(g) of the FD&C Act, 21 U.S.C. 360c(g).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.