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English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...
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.
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 book was distributed for free to all licensed medical doctors in America; only drugs which drug manufacturers paid to appear, appeared in the PDR, and no generic drugs were listed. The 71st Edition, published in 2017, was the final hardcover edition, weighed in at 4.6 pounds (2.1 kg) and contained information on over 1,000 drugs. [ 1 ]
Medical Devices regulations cover all the topics related to the laws, standards or submissions process, with which compliance is required by manifold national and international bodies to commercialize a medical device
Pharmaceutical codes are used in medical classification to uniquely identify medication. They may uniquely identify an active ingredient , drug system (including inactive ingredients and time-release agents) in general, or a specific pharmaceutical product from a specific manufacturer.
First Databank (FDB) is a major provider of drug and medical device databases that help inform healthcare professionals to make decisions. [1] FDB partners with information system developers to deliver useful medication- and medical device-related information to clinicians, business associates, and patients.
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]