U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. How to Prepare a Pre-Request for Designation (Pre-RFD)
  1. Regulatory Information

GUIDANCE DOCUMENT

How to Prepare a Pre-Request for Designation (Pre-RFD) Guidance for Industry February 2018

Final

How to Prepare a Pre-Request for Designation (Pre-RFD)

Docket Number:
FDA-2017-D-0040
Issued by:
Guidance Issuing Office
Office of Combination Products

Submit electronic comments to Regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

Additional copies of this guidance are available at Combination Products on the FDA.gov website.

For questions on the content of this guidance, contact the Office of Combination Products at combination@fda.gov


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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-2017-D-0040.