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The 1990 Safe Medical Device law originated after an eight-year U.S. congressional inquiry of the Medical Device Amendments of 1976. The 1976 legislation deviated the clarification and proper evaluation of competitive or "substantial equivalence" medical devices. [4]
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Medical halogen penlight: to see into the eye, natural orifices, etc. and to test for pupillary light reflex, etc. Medical ultrasound: to create an image of internal body structures Nasogastric tube: for nasogastric suction or the introduction of food or drugs into the body Nebulizer: to produce aerosols of drugs to be administered by ...
A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness. The FDA calls a device approved in this manner a "Humanitarian Use Device" (HUD).
Single-use medical devices include any medical equipment, instrument or apparatus having the ability to only be used once in a hospital or clinic and then disposed. The Food and Drug Administration defines this as any device entitled by its manufacturer that it is intended use is for one single patient and one procedure only. [ 1 ]
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