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H.R.3095 - Safe Medical Devices Act of 1990 - Congress

    https://www.congress.gov/bill/101st-congress/house-bill/3095
    Safe Medical Devices Act of 1990 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to require medical device user facilities to report to the Secretary of Health and Human Services, the manufacturer, or both whenever they believe there is a probability …

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
    1990: Safe Medical Devices Act (SMDA) Improved postmarket surveillance of devices by: Requiring user facilities such as hospitals and nursing homes to report adverse events …

Medical Device Reporting Regulation History | FDA

    https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/medical-device-reporting-regulation-history

    Overview of the Safe Medical Devices Act of 1990

      https://www.drugwatch.com/fda/safe-medical-device-act/
      The Safe Medical Devices Act of 1990 was a critical step in the FDA’s longtime efforts to monitor the impact of faulty medical devices on public health. But since …

    Safe Medical Device Amendments of 1990 - Wikipedia

      https://en.wikipedia.org/wiki/Safe_Medical_Device_Amendments_of_1990
      Senate agreed to House amendment on October 27, 1990 (Agreed by Voice Vote) Signed into law by President George H. W. Bush on November 28, 1990. Safe Medical Device …

    H.R. 3095 (101 st ): Safe Medical Devices Act of 1990

      https://www.govtrack.us/congress/bills/101/hr3095
      Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the …

    CLINICAL POLICY Reporting Adverse Medical …

      https://health.uconn.edu/policies/wp-content/uploads/sites/28/2021/07/Reporting-Adverse-Medical-Device-Incidents-11-032.pdf
      Reporting Adverse Medical Device Incidents . A. EFFECTIVE DATE : June 30, 2021 . B. PURPOSE : In compliance with the Safe Medical Devices Act of 1990 (Act) it is the …

    Safe Medical Device Act Definition | Arena

      https://www.arenasolutions.com/resources/glossary/safe-medical-device-act/
      The Safe Medical Devices Act (SMDA) of 1990 is a federal law that requires medical device manufacturers and user facilities (i.e., hospitals and ambulatory surgical facilities) to …

    Safe Medical Devices Act (SMDA) of …

      https://bmet.fandom.com/wiki/Safe_Medical_Devices_Act_(SMDA)_of_1990
      In 1990, The Safe Medical Device Act (SMDA) is federal legislation which was designed so that the FDA could quickly be informed of any medical product that has caused or suspected to have caused a …



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