Medical Safety Devices and Reporting for User Facilities

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The Protected Medical Gadgets Act of 1990 (SMDA) imposed important new reporting require-ments on the medical system trade and customers of medical gadgets. SMDA requires consumer amenities to report device-related deaths and critical accidents to the Meals and Drug Administra-tion (FDA) and/or the producer. Though the consumer facility reporting necessities of SMDA had been mechanically efficient November 28, 1991, this steerage doc is predicated on the ultimate Medical System Reporting (MDR) rule which was printed within the December 11, 1995, Federal Register. The ultimate rule additionally addresses modifications mandated by the Medical System Amendments of 1992.

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Course Features

  • Lectures 6
  • Quizzes 0
  • Duration 2.0 Hours
  • Skill level All level
  • Language English
  • Certificate Yes
  • Assessments Self
  • Medical Device Reporting for User Facilities

    • Lecture 1.1 Introduction Locked
    • Lecture 1.2 User Facility Reporting Requirements Locked
    • Lecture 1.3 Written Procedures, Record Keeping, and Public Disclosure Locked
    • Lecture 1.4 Enforcement Locked
    • Lecture 1.5 Definitions Locked
    • Lecture 1.6 Frequently asked questions Locked
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