Regulatory Insight has extensive experience negotiating the optimal approach to obtaining market approval or clearance for a specific medical device or IVD with the U.S. Food and Drug Administration. This translates directly into cost savings and faster time to market for a company’s product(s).
FDA classifies medical devices in the United States as Class I, II or III. However, it is far more complicated than that. Most Class I devices are 510(k)-exempt, but not all. Most Class II devices require a 510(k), but some are 510(k)-exempt. Some Class III devices require a PMA and some only require a 510(k).
Novel devices are often classified by the FDA as Class III simply because there is no predicate device. However, Section 513(f) of the Food, Drug and Cosmetic Act allows the sponsor of a novel device to submit a de novo application for potential reclassification of their novel Class III device to a Class I or II device, eliminating the need for a costly and time-consuming PMA.
Regulatory Insight specializes in the following types of U.S. FDA regulatory submissions: |
