The U.S. FDA defines a medical device as follows: A medical device is an instrument, apparatus, appliance, machine, appliance, implant, in vitro reagent, and other similar or related article, including parts or accessories, that meets the following conditions. Affects the structural function of the human body or other animals and does not achieve its intended use through a chemical reaction in the human body or animal, nor does it rely on the production of metabolic changes to obtain any of its intended uses.
The FDA specifies its product classification and regulatory requirements for each medical device, and there are currently more than 1,700 types of medical devices in the FDA's Medical Device Catalog***, and you need to refer to the product's detailed specification for details on how to classify them. According to the different risk levels, the FDA will be divided into three classes of medical devices (Ⅰ, Ⅱ, Ⅲ), Class I for the "general management" of the product, refers to the risk of small or basically non-hazardous products, accounting for about 25% of all medical device varieties. Class II is the "implementation of standard management" products, refers to products with a certain degree of risk, accounting for about 55% of all medical device varieties. Class III is products with greater danger or hazard, or used to support the maintenance of life, accounting for about 20% of all medical devices. The implementation of "pre-market approval" (PMA) system.