US FDA 510(k), PMA, De Novo

Regulatory Insight has extensive experience negotiating the optimal approach to obtaining market approval, clearance, or reclassification 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 also prepares and submits Pre-Submissions (Pre-Subs), particularly in regard to PMAs and De Novo applications in order to gain concurrence from the FDA on the regulatory strategy and contents of the applications.
 

Regulatory Insight specializes in the following types of U.S. FDA regulatory submissions:

 

• 510(k)s Premarket Notifications (including Abbreviated 510(k)s & Special 510(k)s)

• PMA Premarket Approval Applications (including PMA Supplements)

• De Novo Requests

• Establishment Registrations and Device Listings

• Product Reports for Radiation Health

• 513(g) Requests for Classification Information

• Q-Subs / Pre-Subs

• IDE Submissions

• RFD Requests for Designation Submissions to the Office of Combination Products