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

摘要

The Food and Drug Administration (FDA), Center for Devices and Radiological Health, is requesting comments concerning the feasibility of including information for device investigations for serious or life- threatening diseases and conditions in a public data bank. This action is being taken 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 announcing an open public meeting on this subject.