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701 Labeling requirements; The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4] 860 et seq. Listing of specific approved devices and how they are classified; The 900 series covers mammography ...
The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising.
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 ...
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 FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10] In the 1970s, Congress responded to the public's desire for additional oversight over medical devices by passing the Medical Device Amendments of 1976 (MDA) to the FD&C.
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.
For instance, a regulatory agency (such as CE or FDA) may ensure that a product has been validated for general use before approval. An individual laboratory that introduces such an approved medical device may then not need to perform their own validation, but generally still need to perform verification to ensure that the device works correctly ...
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...