Understanding the FDA Device Approval Process in FPMRS

AbstractPurpose of ReviewThis 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 FindingsBringing 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.SummaryWhile 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.
Source: Current Bladder Dysfunction Reports - Category: Urology & Nephrology Source Type: research