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860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography quality requirements enforced by CDRH. The 1000 series covers radiation-emitting device (e.g. cell phones, lasers, x-ray generators); requirements enforced by the Center for Devices and Radiological Health. It also talks about the FDA ...
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]
Classification Panels for Medical Devices. Classification panels are to determine which devices intended for human use should be subject to the requirements of class I - general controls, class II - performance standards, or class III - premarket approval. Classification panels are to provide notice to the manufacturers and importers of medical ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
In the U.S., under the Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act, certain accurate information is a requirement to appear on labels of cosmetic products. [6] In Canada, the regulatory guideline is the Cosmetic Regulations. [7] Ingredient names must comply by law with EU requirements by using INCI names. [8]
The act also codified FDA regulations and practice to increase patient access to experimental drugs and medical devices and to accelerate review of important new medications. In addition, the law provided for an expanded database on clinical trials, ClinicalTrials.gov. [7]