As FDA 510k consultants we can file an FDA 510(k) submission for your Class II medical device or IVD (In Vitro Diagnostics) with the Food and Drug Administration.
What is an FDA 510k?
A 510(k) is a premarket notification submission made to FDA to demonstrate that the medical device to be marketed is at least as safe and effective, that is ‘substantially equivalent’ (SE), to another medical device (predicate device) legally marketed in the USA.
ISOplanUSA can help you to collect and prepare the supporting documentation which compares your medical device to one or more similar legally marketed medical devices (predicate devices) and then make and support your substantial equivalency claims.
Substantial equivalence (SE) means that the new medical device is at least as safe and effective as the predicate device.
A medical device cannot be marketed in the U.S.A. until the submitter receives a clearance letter by FDA declaring the medical device is substantially equivalent to the predicate device.
Who must submit a FDA 510k Premarket Notification?
Medical device manufacturers or distributors introducing Class II medical devices to the US market must submit a 510(k) to the FDA.
An FDA 510(k) is also required for manufacturers changing the intended use of their medical device, or changing the technology of an FDA approved medical device in such a way that it may significantly affect the device’s safety or effectiveness. See Special FDA 510(k).
ISOplanUSA can assist you in understanding U.S. FDA submission documentation requirements, developing a Traditional 510(k), an Abbreviated 510(k) or a Special 510(k) submission which meets FDA expectations.
How to submit a FDA 510k?
If you think that your medical device is similar to others already marketed in the USA, ISOplan USA can help. After confirming the product is either a Class II medical device or a Class I medical device that is not exempt from the premarket notification requirements, ISOplan USA can assist you in the filing of an FDA 510(k) submission.