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Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
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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]
The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” [1] whose goal was the standardization of medical device regulation across the world.
Most of these are accompanied by a short description or definition, links to related descriptors, and a list of synonyms or very similar terms (known as entry terms). MeSH contains approximately 30,000 entries (as of 2025 [update] ) and is updated annually to reflect changes in medicine and medical terminology. [ 3 ]
External links to medical information Template parameters [Edit template data] This template prefers block formatting of parameters. Parameter Description Type Status QID QID Wikidata number Unknown suggested ICD11 ICD11 no description Unknown optional ICD10 ICD10 Note: ICD-10-CM has a separate parameter Unknown suggested ICD10CM ICD10CM no description Unknown optional ICD9 ICD9 no description ...
Jurisdiction Definition Legislation Australia A medical device that: (a) is made specifically in accordance with a request by a health professional specifying the design characteristics or construction of the medical device; and (b) is intended: (i) to be used only in relation to a particular individual; or (ii) to be used by the health professional to meet special needs arising in the course ...