Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff

Issue Date: March 19, 1999
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Investigational Device Exemption (IDE)
Status: Final

Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff

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.

Download the Guidance Document