What is FDA 510(k) Clearances?
Section 510(k) of the Food, Drug and Cosmetic Act
Requires device manufacturers who must register
Notify FDA of their intent to market a medical device at least 90 days in advance
his is known as Premarket Notification – also called PMN or 510(k)
US FDA needs all formatlities to be completed
Post detailed review 510(k) clearance is provided by FDA
Field of LawBusiness (Corporate)
Service TypeLegal AssistanceWhat’s includedThese options are included with the project scope.
- Delivery Time7 days
- Number of Revisions2