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A History of Medical Device Regulation and Oversight in …

    https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states
    1906: Pure Food and Drugs Act (sometimes also called the Federal Food and Drugs Act) Established the precursor to today’s FDA Prohibited interstate commerce of misbranded and adulterated food,...

Medical Examination of Immigrants at Ellis …

    https://journalofethics.ama-assn.org/article/medical-examination-immigrants-ellis-island/2008-04
    While admission decisions were made by the Immigration Service (IS), the law required medical inspection of …

Medical Device Safety Program - California

    https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/MedicalDeviceSafetyProgram.aspx
    The Medical Device Safety Section's mission is to provide an uncompromising standard of public health protection by assuring that medical devices produced and retailed in …

Review and Update of Device Establishment Inspection …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/review-and-update-device-establishment-inspection-processes-and-standards
    FDA is issuing this guidance to comply with section 702 (b) (1) of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs FDA to issue guidance that …

FDA Inspections for Medical Manufacturing Companies

    https://bmpmedical.com/3-types-fda-inspections-means-medical-manufacturing-companies/
    Medical device companies will most likely face three types of inspections by FDA: a pre-approval inspection, a routine inspection, and a compliance follow-up inspection. …

VHA Office of the Medical Inspector - Veterans Health …

    https://www.va.gov/health/medicalinspector/
    The Office of Medical Inspector strives to continually improve the quality of Veterans' health care by investigating issues related to the quality of care, including those …

Clinical Laboratory Improvement …

    https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA
    The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory …

Inspections, Investigations, and Recordkeeping

    https://www.osha.gov/laws-regs/oshact/section_8
    Each employer shall make, keep and preserve, and make available to the Secretary or the Secretary of Health and Human Services, such records regarding his activities relating to …

NMC Act | NMC

    https://www.nmc.org.in/nmc-act/
    The Third Schedule of IMC Act; Right to Information; Rules & Regulations. Rules & Regulations, NMC. Establishment of Medical College Regulation,(Amendment), …

Federal Register :: Medical Devices; Medical Device …

    https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-device-classification-regulations-to-conform-to-medical-software-provisions
    An MDDS is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (1) …



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