The U.S. Food and Drug Administration (FDA) regulate the sale and production of medical devices. FDA issues rules about classification, registration, approvals, product labelling requirements, and quality control for medical devices.<\/p>\n
FDA regulations apply to both imported and manufactured medical devices.\u00a0A branch of the FDA, the Center for Devices and Radiological Health, oversees the implementation of regulations for the sale and production of medical devices in the U.S. and safety and performance.<\/p>\n
1938 saw the passage of the Food, Drug, and Cosmetics Act by Congress. The FDA has the power to enact regulations that affect the sale and production of medical devices in the United States under the FDCA.<\/p>\n
The FDA maintains a classification system that categorizes medical devices into classes I, II, and III<\/a><\/em>. The classification level determines the level of risk. Devices classified as Class I are not subject to regulation, but devices classified as Class III are subject to stricter controls to ensure safety and effectiveness.<\/p>\n \u00a0<\/p>\n FDA Class I medical devices, which are FDA-approved, are the least dangerous and most likely to cause injury. Because they are not subject to general controls, Class I medical devices do not have to be subject to any special regulations. Therefore, they are often exempted from the premarket notification requirements and reasonable manufacturing practice requirements.<\/p>\n These devices are categorized as low-risk and include nonelectric wheelchairs, bandages, toothpaste, and dental floss. Many Class I devices are common everyday items that are unlikely cause any severe problems in the event of a malfunction.<\/p>\n \u00a0<\/p>\n Class II medical devices pose an intermediate risk. These devices require additional controls to the general controls. These unique controls include post-market surveillance and performance standards. Most medical devices are classified as Class II. Some examples include powered wheelchairs and specific pregnancy test kits.<\/p>\n \u00a0<\/p>\n The highest risk medical devices of Class III pose the most significant risk. They need premarket approval. The FDA must approve them before they can be sold or marketed. These medical devices, often classified as Class III, are of significant importance in maintaining human life or preventing health impairments. Implantable pacemakers, cochlear implants, and defibrillators are examples of Class III medical devices.<\/p>\n \u00a0<\/p>\n The FDA’s requirements for good manufacturing practices fall under the QSR. Medical device manufacturers must adhere to the QSR framework to ensure quality control. The FDA sets out specific procedures for manufacturing devices for human consumption.<\/p>\n \u00a0<\/p>\nClass I Medical Devices<\/h2>\n
Class 2 Medical Devices<\/h2>\n
Class 3 Medical Devices<\/h2>\n
FDA Medical Device Good Manufacturing Practices<\/h2>\n
Labeling requirements for FDA Medical Devices<\/h2>\n