Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Device standards: the view from the FDA.

R J Cangelosi

    Journal of Clinical Engineering
    |December 13, 1979
    PubMed
    Summary
    This summary is machine-generated.

    This paper overviews the Food and Drug Administration's (FDA) medical device functions and standards. It details voluntary policies, mandatory standard requirements, and the clinical engineer's role in developing new medical device standards.

    Related Concept Videos

    You might also read

    Related Articles

    Articles linked to this work by shared authors, journal, and citation graph.

    Sort by
    Same author

    Government standards activities.

    JAAMI : journal of the Association for the Advancement of Medical Instrumentation·1971
    Same author

    Studies on experimental retinitis. Light and electron microscopy.

    The British journal of ophthalmology·1971
    Same journal

    US Food and Drug Administration Seeks Input From Healthcare Technology Management Community on Medical Device Supply Disruption During COVID-19 Pandemic.

    Journal of clinical engineering·2021
    Same journal

    Observations on COVID-19.

    Journal of clinical engineering·2021
    Same journal

    Medical computing over the World Wide Web: use of forms and CGI scripts for constructing medical algorithm Web pages.

    Journal of clinical engineering·1999
    Same journal

    Utilization of the Internet to deliver educational materials to healthcare professionals.

    Journal of clinical engineering·1999
    Same journal

    Computer-aided learning--a solution for the training needs of users & maintainers of medical equipment.

    Journal of clinical engineering·1999
    Same journal

    A study on the current situation in the biomedical technology and clinical engineering sector in Bulgaria--advances, trends and needs.

    Journal of clinical engineering·1999
    See all related articles

    Area of Science:

    • Medical Device Regulation
    • Standards Development
    • Public Health Policy

    Background:

    • Overview of the Food and Drug Administration's (FDA) regulatory functions and activities concerning medical devices.
    • Introduction to the Medical Device Amendments and performance standard requirements.
    • Exploration of the FDA's perspective on medical device standards.

    Purpose of the Study:

    • To provide a comprehensive overview of the FDA's role in medical device standards.
    • To discuss the agency's policies on voluntary standards and conditions for deferring mandatory standards.
    • To introduce the process of new standards development, including Problem Definition Studies.

    Main Methods:

    • Review of FDA's functions and activities related to medical device regulation.

    Related Experiment Videos

  • Analysis of the Medical Device Amendments and performance standard requirements.
  • Description of the FDA's voluntary standards policy and deferral conditions for mandatory standards.

    • Main Results:

    • The paper outlines the FDA's approach to medical device standards, including voluntary policies and mandatory requirements.
    • It details the Medical Device Standards Survey and the significance of clinical engineers in the standards development process.
    • New Problem Definition Studies by the Bureau of Medical Devices are presented as the initial phase of standards development.

    Conclusions:

    • The FDA plays a crucial role in establishing and enforcing medical device standards to ensure public safety.
    • The agency encourages voluntary standards while outlining criteria for mandatory standards.
    • A structured process, including Problem Definition Studies, is in place for developing new medical device standards.