FDA Report for Safer Medical Products for Healthcare Providers

The following FDA Report for Safer Medical Products for Healthcare Providers is designed to educate healthcare providers (HCP) on how to report medical device malfunctions, serious injuries, or deaths associated with medical devices to the FDA. 

Upon completion of this course, learners should be able to:

• Recognize when a medical device event meets applicable FDA medical device reporting requirements in healthcare practice.

• Report qualifying medical device events using the appropriate FDA reporting process and required documentation.

What you will learn: 

• Introduction to Medical Device Reporting

  • Summary of MDR Regulation

• Reporting Requirements

  • Mandatory vs voluntary MDR requirements

• Reporting Guidelines

  • How to report a medical device problem

Once completed, you will receive a certificate of completion to verify you have finished the training. Course Length: 45 minutes.

American Medical Compliance, Inc. (AMC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s Commission on Accreditation. AMC designates this activity for 0.75 contact hours. Learners must complete the entire activity, including passing the quiz on the first or second attempt, to receive credit.

American Medical Compliance is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education to physicians.  American Medical Compliance designates this activity for a maximum of 0.75 AMA PRA Category 1 CreditsTM.  Physicians should only claim this credit for their complete participation in this activity.

Providers approved by California Board of Registered Nursing. Provider # 18138 for 0.75 Contact Hours.

No relevant financial relationships exist for any individual in a position to control the content of the educational activity.

Our continuing education program is committed to enhancing the knowledge, skills, and professional performance of healthcare professionals as they strive to improve patient care outcomes and maintain a safe workspace. Through high-quality educational activities, we aim to address identified educational needs that support the continuous professional development of our healthcare community.

The information contained in these trainings was derived from publications of OSHA, EEOC, DOL, OCR, FDA, CDC, NIAID, ATSDR, HHS or WHO (Government Sourced Material). The Government Sourced Material used by AMC is available for no charge on their associated websites. The use of the Government Sourced Material by AMC does not imply endorsement or recommendation by OSHA, EEOC, DOL, OCR, FDA, CDC, NIAID, ATSDR, HHS or WHO or by the United States Government, of AMC, its enterprise, its facility, its services or its products. © 2027 American Medical Compliance, no copyright claimed in the State and Government Sourced Material. If you are not completely satisfied with this course within 30 days you will receive a full refund.