Public Availability of Information on Clinical Trials for Investigational Devices Intended to Treat Serious or Life-Threatening Conditions; Meeting

Streszczenie

The Food and Drug Administration (FDA) is announcing a meeting concerning the public availability of information on clinical trials for investigational devices intended to treat serious or life- threatening conditions and the availability of this information in a publicly available data bank. This meeting is being held to assist the agency in preparing a report to Congress required under the FDA Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is inviting written comments and information that may assist FDA in this endeavor.