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# Request for Information Guidance
- URL: https://www.fdaweb.com/request-for-information-guidance/
- Published: 2024-08-22T12:00:00.000Z
- Updated: 2026-09-14T14:39:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157635

FDA has published a guidance, *FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act*, establishing procedures for submitting, reviewing, and responding to requests for information regarding the class in which a medical device has been classified or the requirements applicable to a device under section 513(g) of the Federal Food, Drug, and Cosmetic Act. The [document](https://www.fda.gov/media/78456/download?ref=fdaweb.com) contains an Introduction, Statutory Requirements for Device Classification, Obtaining Information About a Device, Submitting a 513(g) Request for Information, Contents of a 513(g) Request for Information, Responding to a 513(g) Request for Information in CDRH or CBER, and Paperwork Reduction Act of 1995.