Assessment of Obstetric and Gynecologic Food and Drug Administration Device Approvals and Recalls.

Abstract

To evaluate and compare the recall rates of obstetric and gynecologic devices approved via the Food and Drug Administration's 510(k) and premarket approval (PMA) processes. A retrospective observational study (Canadian Task Force classification II-2). Clinical settings in the United States that use obstetric and gynecologic devices. Two thousand two hundred forty-nine Food and Drug Administration-approved obstetric and gynecologic devices that were recalled between November 1, 2002, and December