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Home medical equipment is a category of devices used for patients whose care is being managed from a home or other private facility managed by a nonprofessional caregiver or family member. It is often referred to as "durable" medical equipment (DME) as it is intended to withstand repeated use by non-professionals or the patient, and is ...
The FDA’s Center for Devices and Radiological Health says on the FDA site: “Complex medical devices are used more frequently in the home, many times under unsuitable conditions.
I. Ice pack; Impedance cardiography; Inadine; Incentive spirometer; Incubator (culture) Inhaler spacer; Injector pen; Instruments used in cardiology; Instruments used in dermatology
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).
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