Draft Guidance for Industry
This guidance document is being distributed for comment purposes only.
Submit one set of either electronic or written comments on this draft guidance bythe date provided in the Federal Register notice announcing the availability of the draft guidance.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 regulations.gov. 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 FDA.gov website at this link: Combination Products Guidance Documents.
For questions on the content of this guidance, contact the Office of Combination Products at email@example.com
U.S. Department of Health and Human Services
Food and Drug Administration
Office of Combination Products in the Office of the Commissioner