Understanding the FDA Device Approval Process in FPMRS

Purpose of Review: This review will provide an understanding of the FDA device approval process, particularly with respect to medical devices used in female pelvic medicine and reconstructive surgery. Recent Findings: Bringing a novel medical device to the market through the FDA regulatory process can be broken down into four steps: device classification, selecting and preparing premarket-submission regulatory pathways, FDA review of premarket-submissions, and postmarket regulatory controls. Summary: While the FDA regulatory process can be daunting, physicians and surgeons have the responsibility toward unmet needs of patients and should be at the helm of medical device innovation.