FDA 510(k) Application of Medical Device
America FDA is an agency of the United States Department of Healthy and Human Service.The FDA is responsible for protecting and promoting public healthy through the regulation and supervision of food safety, drug, cosmetic, and electromagnetic radiation emitting devices, is also the earliest institute of consumer protection.
According to risk class, FDA define medical device as three classification (Ⅰ，Ⅱ，Ⅲ), class Ⅲ is the highest risk products. To all medical devices, company should do registration and listing.
Class Ⅰ products (about 47%), applicable General Control, and most of the products should do registration, listing and implement cGMP requirements, and the device can be put into US market(for some product GMP is exempted, and a very few products need 510(k) Premarket Notification(PMN) application to FDA).
Class Ⅱ products (about 46%) is under Special Control. After Registration and listing, Company should implement GMP, and submit 510(k) application (a very few product is exempted for 510(k)).
Class Ⅲ devices (about 7%) should have Premarket Approval (PMA), After Registration and Listing, manufacturer should implement GMP, and submit Premarket Approval (PMA) application (Some Class Ⅲ still need PMN).
For some class Ⅰ and Ⅱ, 510(k) is not needed at the first marketing time. And the exempted device can be found on exemption list.
We will help you finish the whole process of 510(k) application, and get the approval of US FDA, and get the ticket of US market.
