The cost of applying for a Certificate of Free Sale in the U.S. for Medical Devices depends on the type and procedure requested. Here are some of the costs that may be involved:
510(k) AMC Fee: Currently, (as of the 2022 deadline for my knowledge), FDA charges a 510(k) AMC filing fee. According to FDA regulations, the filing fee depends on the classification of the medical device and how it is filed, and usually ranges from a few thousand dollars to tens of thousands of dollars. The exact fees can be found on the FDA's official ** for the most up-to-date fee information.
PMA Approval Fee: There is a fee to be paid for filing a PMA application. The cost of a PMA application is relatively high, often ranging from hundreds of thousands of dollars to millions of dollars, depending on the type and complexity of the medical device being filed.
Other costs: In addition to the application fee, the manufacturer may also need to bear other costs such as clinical trials, testing, document preparation, consultant fees, etc.
It is important to note that these fees are only part of the cost of applying for a medical device sales license. Manufacturers also need to consider other costs in terms of R&D, production, marketing, etc. Filing fees are subject to change based on FDA regulations and policies, so manufacturers are advised to consult FDA's latest fee regulations before submitting an application.