-
es338 replied to the topic 510(k) clearance vs. Postmarket Approval in the forum Introduction to Project Management 7 years, 2 months ago
FDA 510(k) submissions are for class II devices that have already been approved in the market since the FDA passed the Medical Device Amendments Act in May 28th, 1976. When submitting a 510(k), the device must be compared to other legally marketed devices in the U.S.. 510(k) submission requirements are detailed in 21 CFR 807 Subpart E. IF the FDA does not believe that the device is substantially equivalent to a predicate device, then either a new 510(k) submission with new data, request for Class II designation (De Novo), file for a reclassification petition, or a pre-market approval (PMA) is necessary. A De Novo classification request is based on general controls that provides assurance of safety and intention of use, for devices that do no have legally marketed predicate devices. Only Class I and Class II devices, based on risk, are eligible for De Novo requests.
