산부인과 치료를 위한 새로운 의료 장치를 평가하고 채택하는 방법: ACOG 위원회 의견, 번호 801.

초록

The purpose of this document is: 1) to help obstetrician-gynecologists better understand the U.S. Food and Drug Administration's regulatory process for the marketing of medical devices; 2) to educate obstetrician-gynecologists on the importance of understanding available evidence on the safety, efficacy, and indications for devices in clinical practice; 3) to encourage obstetrician-gynecologists to report safety events associated with medical devices; and 4) to provide guidance on what to consid