Published in:
01-09-2021 | Reconstructed Bladder Function & Dysfunction (M Kaufman, Section Editor)
Understanding the FDA Device Approval Process in FPMRS
Published in: Current Bladder Dysfunction Reports | Issue 3/2021
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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.