Retrospective Study of the FDA Database for High Risk Medical Device Approvals in Obstetrics & Gynecology [8E]

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The newly proposed 21st Century Cures Act would lead to significant changes to medical device regulation. Recent controversies surrounding pelvic meshes and morcellators highlight the need for better understanding surrounding the regulation and approval of high-risk devices in Obstetrics and Gynecology (OBGYN).


The FDA database was reviewed for device approvals assigned to the OBGYN advisory committee along the pre-market approval pathway from 2000–2015. The quality of the pivotal studies leading to approval were extracted from the summary of safety and effectiveness data.


There were 18 approvals between 2000–2015. The OBGYN advisory committee recommended nine devices for approval and recommended against approval for two devices. Seven devices were not referred for formal review. Three devices have been withdrawn following approval, all of which were either not referred or initially rejected by the committee. Four devices were granted expedited status. The median approval time was 290 days (range 178–1,399). Indications included endometrial ablation (33%), contraception (28%) and fetal monitoring (17%). In total, there were 11 randomized controlled trials, one randomized cross-over study, five non-randomized prospective studies and two human factor studies. 13 of 18 devices required post-market surveillance.


Compared to other medical specialties, OBGYN ranked 9th out of 17 specialties in high-risk device approvals from 2000–2015. These devices were more likely to be approved based on RCTs compared to prior studies on Cardiology and Gastroenterology devices. The last six years have led to only one device approval suggesting the need to spur device innovation in OBGYN.

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