Regulatory Information

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

Guidance for Industry

February 2018

PDF Printer Version - 343KB

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

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