Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects
This guide is intended to clarify section 812.7 of 21 CFR Part 812, the regulations providing procedures for investigational device exemptions (OMB CONTROL NUMBER 0910- 0078). This section prohibits the promotion or test marketing of investigational medical devices.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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 comments should be identified with the title of the guidance.