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  2. 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

  3. FDA Center for Devices and Radiological Health - Wikipedia

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

    Globally, CDRH fosters quality and enables harmonization of quality management system requirements across regulatory jurisdictions. In early 2024, FDA issued a final rule [ 30 ] amending the device current good manufacturing requirements to align more closely with the international consensus standards set by International Organization for ...

  4. ISO 13485 - Wikipedia

    en.wikipedia.org/wiki/ISO_13485

    ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.

  5. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]

  6. Quality management system - Wikipedia

    en.wikipedia.org/wiki/Quality_management_system

    As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements. The FDA ...

  7. 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 ...

  8. Clinical Laboratory Improvement Amendments - Wikipedia

    en.wikipedia.org/wiki/Clinical_Laboratory...

    Calibration, quality control, and proficiency testing materials; Test system troubleshooting and equipment maintenance; Interpretation and judgment; Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State ...

  9. Design controls - Wikipedia

    en.wikipedia.org/wiki/Design_controls

    The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...