Juniper Publishers - FDA 510 (k) Process- How To Get It Right The First Time?
Cancer Therapy & Oncology International Journal Abstract The medical devices that are designated to be marketed need to go through a clearance process set forth by FDA. The Premarket notification (PMN) or 510(k) is the most common regulatory pathway in US but poses many challenges to medical device manufacturers. FDA has cleared more than 1, 40,000 medical devices since 1976. This is a clearance process, and not an approval, for medical devices. 510(K) submission has a purpose, a process and should be well understood in order to avoid unnecessary delays and failures. Keywords: Medical device; Regulation; FDA; 510(K); Substantially Equivalent Abbreviations: FDA: Food and Drug Administration, PMA: Premarket Approval; SE: Substantially Equivalent; Introduction Getting a clearance letter from FDA on 510(K) for a medical device is a milestone and the ultimate goal for any medical device manufacturer, be it a small ...