Medical device manufacturers of class II medical devices, which want to legally market their products in the US, necessiate an FDA-clearence for their devices. This process is a submission of documentation according to chapter 510(k) of the Federal Food, Drug, and Cosmetic Act, which allows FDA to determine if the medical device is substential equivalent to already legally marketed predicate devices in the US. Is the evidence of substencial equivalence not obvious to the FDA, the manufacturer might need to obtain a PMA approval instead.

Not only marketing a new product in the US, but also changing an existing design of a marketed device might lead to a new 510(k). Further development of the product portfolio should therefore always be performed in close collaboration with regulatory affairs professionals.

PROSYSTEM offers a comprehensive package for the compilation and submission of your 510(k):

• Analysis of the respective medical device for classification and identification of the regulation number
• Listing of all documents required for a 510(k)
• Identification of one or more predicate devices
• Analysis of all relevant FDA Guidelines
• Preparation of all relevant chapters of the 510(k)
• Coordination of FDA response
• Support of the 510(k) submission fee payment process

If you currently do not have legally marketed devices in the US we support you with your Registration and Listing.

Contact us for further details or request a non-binding quotation.