How to Prepare a Pre-Request for Designation (Pre-RFD)
- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice 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 firstname.lastname@example.org
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.