At present, the FDA has divided medical device registration into three categories, the first category is the lowest risk products, most of which can be registered directly, such as eyeglasses, cotton swabs, etc.; the second category is the higher risk products, most of the Class II products and a small number of Class I high-risk products are required to carry out the pre-market notification (510k) to get the 510k number to carry out the registration listing, such as contact contact lenses. registration listing, such as contact contact lenses, medical masks, etc.; the third category is the highest risk level products, need to do pre-market application, this application is difficult, such as artificial heart, etc..
The FDA not only divides products into three main categories, but also codes each detailed classification and publishes its definitions and regulations. For example, the masks that were a big hit during the epidemic, the FDA currently has almost a dozen Product codes for the masks' classifications, certain ones that are Class I, certain ones that are Class II but exempt from the 510k, and certain ones that require a 510k to be listed.
The first step in registration is to determine whether your product is under the jurisdiction of the FDA, and if so, which Product code it is, and then register it according to the requirements of that Product code.
If the product has been announced on the official website as a Class I product, you can directly enter the FDA online registration system for medical devices to apply for an account and pay the registration fee directly;
If it is a product that requires a 510k, you need to get a 510k number before you can register it.The application process for the 510k (pre-market notification) is more complicated, including but not limited to The 510k application process is complex and includes, but is not limited to, applicable standards and testing programs, comparative counseling on similar products, preparation of technical documents, filing with the FDA, and payment of the official fee for the 510k application (which varies from year to year, and will be $12,745 in 2022.) After the FDA has completed its review, and has verified that the product's risk level is consistent with the risk level of similar products currently available in the U.S. market, the product will be assigned a 510k number. After receiving the 510k number, as in the previous case, then enter the FDA online medical device registration system to apply for an account and pay the fee to register;
If it is a Class III PMA, then you need to complete the PMA application, which includes, but is not limited to, the device does not have "substantial equivalence" (SE), The PMA application includes, but is not limited to, the absence of "substantial equivalence" (SE) of the device, "new product" - no "substantial equivalence" evaluation of benchmarks, clinical data to demonstrate the safety and efficacy of the device and so on. After obtaining this, you can enter the FDA's online medical device registration system to apply for an account and pay for registration. Click here to learn about FDA regulatory requirements for free