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  2. Medical Device Regulation Act - Wikipedia

    en.wikipedia.org/wiki/Medical_Device_Regulation_Act

    Medical device cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness of the device. Medical device is to be for use in supporting or sustaining human life, of substantial importance in preventing impairment ...

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

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

    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 quality requirements enforced ...

  4. 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]

  5. Title 21 CFR Part 11 - Wikipedia

    en.wikipedia.org/wiki/Title_21_CFR_Part_11

    A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. [3] The rule also applies to submissions made to the FDA in electronic format (e.g., a New Drug Application) but not to paper submissions by electronic methods (i.e., faxes). It ...

  6. Medical device - Wikipedia

    en.wikipedia.org/wiki/Medical_device

    This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...

  7. Category:Regulation of medical devices - Wikipedia

    en.wikipedia.org/wiki/Category:Regulation_of...

    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