<P> Examples include surgical instruments (Class I), contact lenses and ultrasound scanners (Class II), orthopedic implants and hemodialysis machines (Class III), and cardiac pacemakers (Class IV). </P> <P> Under the Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness . The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860). The USFDA allows for two regulatory pathways that allow the marketing of medical devices . The first, and by far the most common is the so - called 510 (k) process (named after the CFR section that describes the process). A new medical device that can be demonstrated to be "substantially equivalent" to a previously legally marketed device can be "cleared" by the FDA for marketing as long as the general and special controls, as described below, are met . The vast majority of new medical devices (99%) enter the marketplace via this process . The 510 (k) pathway rarely requires clinical trials . The second regulatory pathway for new medical devices is the Premarket Approval process, described below, which is similar to the pathway for a new drug approval . Typically, clinical trials are required for this premarket approval pathway . </P> <P> Class I devices are subject to the least regulatory control . Class I devices are subject to "General Controls" as are Class II and Class III devices . General controls include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices . Class I devices are not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury . Most Class I devices are exempt from the premarket notification and a few are also exempted from most good manufacturing practices regulation . Examples of Class I devices include elastic bandages, examination gloves, and hand - held surgical instruments . </P> <P> Class II devices are those for which general controls alone cannot assure safety and effectiveness, and existing methods are available that provide such assurances . In addition to complying with general controls, Class II devices are also subject to special controls . A few Class II devices are exempt from the premarket notification . Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance . Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user . Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, and surgical drapes . </P>

What is an fda class 1 medical device
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