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Safe Medical Devices Act

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Satisfactory completion requirements: All disciplines must complete learning assessments to be awarded credit, no minimum score required unless otherwise specified within the course.

MedBridge is committed to accessibility for all of our subscribers. If you are in need of a disability-related accommodation, please contact [email protected]. We will process requests for reasonable accommodation and will provide reasonable accommodations where appropriate, in a prompt and efficient manner.

Accreditation Check:

The U.S. Food and Drug Administration requires certain healthcare organizations to report serious issues with medical devices. In this course, you will learn the requirements of the Safe Medical Devices Act, including procedures to report serious injuries and even death, and why reporting is important.

This course helps meet the requirements for the Safe Medical Devices Act and the FDA's Medical Device Reporting regulation 21 CFR 803. It also aligns with ACHC home health and hospice standards.

Estimated Runtime: 10 minutes
Last Updated: November 1, 2021


Publication Year: 2022 Reviewed and approved by
Nancy Allen, BSN, RNC, CMC

NOTE: This course is not a substitute for legal advice for any individual provider or situation. Always consult your company's legal or compliance personnel with any questions or concerns related to this subject matter.

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