비즈니스 · 1999. 6. 22.1 분 읽기
Public Availability of Information on Clinical Trials for Investigational Devices Intended to Treat Serious or Life-Threatening Conditions; Request for Comments
로컬 자동 번역 · 원본 출처 언어
요약
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.