510(k) is a pre-market submission filed at the FDA by the manufacturer who intends on releasing a medical device into the market. A 510(k) basically demonstrates that the device to be marketed is, if not superior, at least as safe and effective as the the device to which it is substantially equivalent. It is essential that the submitters compare their device to one or more similar legally marketed devices to support their substantial equivalency claims.
However, 510(k) is applicable only for those devices which are exempt from Class I or for devices which do not need Premarket Approval (PMA). This submission must be done at least 90 days in advance.
510(k) submitted can be grouped into 3 categories:
Traditional 510(k)- Applies to any original 510(k) or for devices which have filed for modification to a previously 510(k) cleared device.
Abbreviated 510(k)- Applies to those devices which have guidance documents or established special control, or relevant consensus standard approved by FDA.
Special 510(k)- Applies to those devices for which modifications need to be made to the already existing 510(k) device.
Once the 510(k) application is submitted, an acknowledgement is received within 7 days. If the tests and reports are in place, a successful approval is received within 90 days.
For more information on 510(k) types, submissions and assistance please write to us at firstname.lastname@example.org
Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.