You should submit comments and suggestions regarding this draft document within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this document contact (CDRH) Diane Garcia at 301-796-6559 or, or (CBER) the Office of Communication, Outreach, and Development at 800-835-4709 or 301-827-1800.


U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research


1 An unclassified device is a pre-amendments device for which a classification regulation has not been promulgated. Unclassified devices require submission of a 510(k) premarket notification to CDRH. A not-classified device is a post-amendments device that the Agency has not yet reviewed or for which the Agency has not made a final decision. A pre-amendments device is a device that was on the market prior to the enactment of the Medical Device Amendments to the FD&C Act on May 28, 1976.

2 See Guidance for Evaluation of Automatic Class III Designation.

3 See Convenience Kits Interim Regulatory Guidance.

4 For additional information regarding HUD designation, refer to information on the FDA website.

5 Product Classification Database

6 Product Code Builder (For Foods)

7 See 21 CFR Part 807.

8 Device Advice: Comprehensive Regulatory Assistance

9 How to Register and List

10 Product Classification Database

11 See 21 CFR Part 807.

12 Refer to the Draft Guidance for Industry and FDA Staff: FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act on FDA’s website, and the Draft Guidance for Industry and FDA Staff: User Fees for 513(g) Requests for Classification Information.

13 See