産科および婦科学の新しい医療機器の評価と採用：ACOG委員会意見要約、番号801。

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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