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

Reporting breast implant complications.

Jeanne Prin Wyatt

    Plastic Surgical Nursing : Official Journal of the American Society of Plastic and Reconstructive Surgical Nurses
    |October 10, 2003
    PubMed
    Summary

    The Food and Drug Administration (FDA) defines medical device complaints as communications alleging deficiencies in device safety or effectiveness. Reporting, investigation, and follow-up involve shared responsibilities among the FDA, manufacturers, and healthcare providers.

    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

    Preparing for breast augmentation: informed consent.

    Plastic surgical nursing : official journal of the American Society of Plastic and Reconstructive Surgical Nurses·2005
    Same author

    No quick fix.

    Plastic surgical nursing : official journal of the American Society of Plastic and Reconstructive Surgical Nurses·2004
    See all related articles

    Area of Science:

    • Medical Device Regulation
    • Patient Safety
    • Healthcare Compliance

    Background:

    • The Food and Drug Administration (FDA) provides a clear definition for medical device complaints, encompassing issues related to identity, quality, durability, reliability, safety, effectiveness, or performance.
    • Post-market surveillance is critical for ensuring the ongoing safety and effectiveness of medical devices.

    Purpose of the Study:

    • To outline the regulatory definition of a medical device complaint.
    • To delineate the shared responsibilities in the medical device complaint process.

    Main Methods:

    • Review of FDA regulatory definitions and guidelines.
    • Analysis of the roles and responsibilities of stakeholders in complaint handling.

    Main Results:

    Related Experiment Videos

    • A medical device complaint is defined as any communication alleging deficiencies in a distributed device's characteristics.
    • The process involves interconnected roles for the FDA, manufacturers, and healthcare providers.

    Conclusions:

    • Effective medical device complaint management requires collaboration between regulatory bodies, manufacturers, and healthcare professionals.
    • Clear understanding and execution of these shared responsibilities are essential for post-market device safety and performance.