FDA’s 510(K) Submission Process
The FDA 510(K) Pre-market notification submission as per 21 CFR 807 Subpart E is to be adopted by manufacturers to receive FDA clearance to market medical devices or for commercial distribution in the U.S. This review is done by FDA’s Centre for Devices and Radiological Health (CDRH). A 510(K) submission allows medical devices to be “FDA Cleared” and not FDA Approved. The route to 510(K) must be carefully investigated by the manufacturer through a step-by-step process which allows determin...
