The FDA has developed many bills for medical devices, and from time to time to modify and supplement, but the fundamental bill is not much, including: the Federal Food, Drug & Cosmetic Act (FD&C Act, the fundamental bill); the Public Health Service Act; the Fair Packaging and Labeling Act; the Health and Safety Radiation Control Act; the Safety of Medical Devices Act; the modernization of the bill. For these acts, FDA gives a very detailed explanation, and supporting specific operational requirements. Companies planning to enter the U.S. market need to carefully evaluate their product-related regulations and specific requirements (including the requirements of different U.S. product standards).
After clarifying the above information, companies can begin to prepare the relevant documents and follow certain procedures to file with the FDA to obtain approval. For any product, companies need to carry out enterprise registration (Registration) and product listing (Listing). Class I products (accounting for about 47%), the implementation of the general control (General Control), the vast majority of products only need to be registered, listed and the implementation of GMP specifications, the product can enter the U.S. market (a very small number of products are exempted from the GMP, a very small number of reserved products need to be submitted to the FDA 510 (K) application that is, PMN (Premarket) Notification)); for Class II products (about 46%), the implementation of special control (Special Control), enterprises in the registration and listing, but also need to implement GMP and submit 510 (K) application (very few products are 510 (K) exemption); for Class III products (about 7%), the implementation of the pre-market licensing, the enterprise registration and listing, must implement GMP and 510 (K) application (very few products are 510 (K) exemption); for Class III products (about 7%), the implementation of pre-market licensing, the enterprise registration and listing, must implement GMP and 510 (K) application. For Class III products (about 7%), pre-market authorization is implemented, and after registration and listing, companies must implement GMP and submit a PMA (Premarket Application) application to the FDA (some Class III products are still PMN).