Assessing and Adopting New Medical Devices for Obstetric and Gynecologic Care: ACOG Committee Opinion Summary, Number 801.

Аннотация

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