Why Medical Device Companies Use The FDA Third Party Review Program
Medical device companies use the FDA 510(k) Third Party Review Program as a voluntary alternative for certain low- to moderate-risk devices and is designed to speed up market access for medical device manufacturers. The results are clear. Faster Review Timelines: By delegating the initial technical review to an FDA-accredited Third Party Review Organization (3P510k RO), companies can avoid extended FDA review timelines. […]