Based on the risk leveldifferences, the FDA classifies medical devices into three categories (Ⅰ, Ⅱ, Ⅲ), with Ⅲ having the highest risk level and the most stringent supervision.The FDA Medical Device Product Catalog has included more than 1,700 kinds of products. Any kind of medical device that wants to enter the U.S. market must be under the supervision of the FDA.
Class I Medical Devices: General Control
These devices can ensure their efficacy and safety as long as they are under general control, such as crutches, eyeglass lenses, and adhesive tapes, which account for about 47% of all medical devices.
These controls include: prohibiting the sale of poorly manufactured and mislabeled products; the FDA may prohibit the sale of substandard products; mandatory reporting to the FDA of hazards, repairs, and replacements; and restrictions on the trafficking, sale, and use of certain devices.
Implementation of GMP: Domestic manufacturers, importers, and distributors are required to register with the FDA, and manufacturers are required to list the products that they manufacture, as well as Class II and Class III products.
Class II? Class II Medical Devices: Special Controls
These products are subject to special requirements set by the FDA or other industry-recognized standards, which include medical gloves, motorized wheelchairs, hearing aids, sphygmomanometers, diagnostic catheters, and so on, accounting for about 46 percent of all devices. The FDA has special requirements for mandatory performance standards, patient registration, and post-market surveillance for specific products.
Class III? Class III Medical Devices: Pre-Market Approval
These products are life-sustaining, life-supporting, or implantable devices that are potentially hazardous to patients and may cause injury or disease, such as cardiac pacemakers, intrauterine devices, and incubators for infants, which account for about 7% of all devices. These devices must obtain a PMA from the FDA before they can be sold.