In this 510(k) submission process webinar attendees will learn the different types of 510(k)s, 21 required elements in the traditional 510(k) and how are they addressed and documented. Also attendees will learn software / firmware requirements, De Novo submission for obtaining marketing clearance for medical devices in the U.S.
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process – for Class 2 devices. The U.S. FDA mandates that the traditional 510(k) submission address 21 basic requirements. The "Special" and "Abbreviated" 510(k)s must also address them, but in different ways.
The FDA holds companies responsible for filing new 510(k)s when new products are to be marketed in the U.S., or when existing products and/or their Indications for Use are changed.
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