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  2. Medical Device Regulation Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_Regulation_Act

    Medical Device Amendments of 1976; Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes. Enacted by: the 94th United States Congress: Effective: May 28, 1976: Citations; Public law: 94-295: Statutes at Large: 90 Stat ...

  3. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration

  4. Medical device design - Wikipedia

    en.wikipedia.org/wiki/Medical_device_design

    Medical devices are defined by the US Food and Drug Administration (FDA) as any object or component used in diagnosis, treatment, prevention, or cure of medical conditions or diseases, or affects body structure or function through means other than chemical or metabolic reaction in humans or animals. [2]

  5. FDA Eyes Overhaul of Medical Device Regulation - AOL

    www.aol.com/2010/08/04/fda-medical-device...

    The Food and Drug Administration is proposing a revamp of its regulations of medical devices, according to a report it released Wednesday. While seeking to improve device safety, the FDA also ...

  6. FDA Center for Devices and Radiological Health - Wikipedia

    en.wikipedia.org/wiki/FDA_Center_for_Devices_and...

    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]

  7. FDA Eyes Overhaul of Medical Device Regulation - AOL

    www.aol.com/news/2010-08-04-fda-medical-device...

    The Food and Drug Administration is proposing a revamp of its regulations of medical devices, according to a report it released Wednesday. ... 800-290-4726 more ways to reach us.

  8. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...

  9. Safe Medical Device Amendments of 1990 - Wikipedia

    en.wikipedia.org/wiki/Safe_Medical_Device...

    Safe Medical Device Amendments of 1990; Long title: An Act to amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes. Enacted by: the 101st United States Congress: Effective: November 28, 1990: Citations; Public law: 101-629: Statutes at Large: 104 Stat. 4511 ...

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