Regulatory Information

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

Draft Guidance for Industry

This guidance document is being distributed for comment purposes only.

January 2017

PDF Printer Version - 480KB

Submit one set of either electronic or written comments on this draft guidance bythe date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number, FDA-2017-D-0040.

Additional copies of this guidance are available on the website at this link: Combination Products Guidance Documents.

For questions on the content of this guidance, contact the Office of Combination Products at

U.S. Department of Health and Human Services
Food and Drug Administration
Office of Combination Products in the Office of the Commissioner

Page Last Updated: 01/12/2017
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