FDA implements classified management of medical devices, and divides medical devices into three categories (Ⅰ, Ⅱ, Ⅲ) according to the level of risk and management level for pre-market management, and category Ⅲ has the highest risk level. FDA clearly stipulates its product classification and management requirements for each medical device. At present, there are more than 1,700 kinds of FDA medical device product catalogs. If any medical device wants to enter the U.S. market, it must first clarify the product classification and management requirements for listing.

  The FDA selects a panel of experts from scientific, engineering, and clinical experts, as well as candidates recommended by consumer and industrial organizations, of which consumer and industrial organization representatives do not have voting rights. The FDA will ultimately determine the detailed classification of medical device products based on the recommendations of the expert committee, and the regulatory code base will be updated annually while the results of these classifications are published on a regular basis.

   After the above information is clarified, the enterprise can start to prepare the relevant application materials, and declare to the FDA according to certain procedures to obtain approval. For any product, enterprises need to carry out enterprise registration (Registration) and product listing (Listing).

  Class I products are "General Controls" products, which refer to products with little or no risk, such as medical gloves, tongue depressors, manual surgical instruments, etc. These products account for about 30% of all medical devices. The FDA exempts most of these products from the pre-market notification process. Generally, after the manufacturer submits to the FDA to prove that it complies with GMP and registers, the product can be marketed.

Class II products are "General & Special Controls" products, whose management is based on "general management", but also through the implementation of standard management or special management to ensure product quality and safety effectiveness. Such products account for about 62% of all medical devices. FDA only exempts a small number of Class II products from the premarket notification process, and most of the remaining products require a premarket notification (510K). Manufacturers must submit an application to the FDA 90 days before the product goes on the market, and after passing the 510K review, the product can be marketed.

Class III products are "Pre-market Approval (PMA)" products, which refer to products with higher risks or hazards, or products that support or maintain life, such as artificial heart valves, pacemakers, artificial heart Lenses, artificial blood vessels, etc., such products account for about 8% of all medical devices. The FDA adopts a pre-market approval system for such products. Manufacturers must submit a PMA application and related materials to the FDA before the product is marketed to prove that the product quality meets the requirements and is safe and effective in clinical use. The FDA will notify the manufacturer within 45 days of receiving the PMA application whether to file a case for review of the application, and make a decision on whether to approve the accepted application within 180 days (excluding the time for the manufacturer to re-supplement information). After a decision to approve the application is made, the product can be marketed.

   In general, FDA headquarters conducts premarket notification (510K) or premarket approval (PMA) review for nearly 60% of medical devices