The U.S. Medical Device Reporting regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers and device user facilities to report certain device-related adverse events and product problems to the FDA. This course provides critical information to ensure mandatory reporters maintain compliance with the regulation.
At the end of this module, you will be able to:
- Identify who must report adverse events to FDA
- Recognize how to report adverse events to FDA
- Identify various types of reportable adverse events
- Identify timeframes for reporting
- Recognize how FDA utilizes adverse event reports
- Define exemptions to reporting adverse events
By completing/passing this course, you will attain the certificate Medical Device Certificate
Terms and Conditions Agreement
NSF International is pleased to offer e-learning Courses (the “Course” or “Courses”) for use through this website on the express condition that you agree to and abide by these terms and conditions (the “Agreement”).
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- Links to Other Websites. A Course may contain links to third party websites. Access to any other website linked to the Course is at the user's own risk and NSF is not responsible for the accuracy or reliability of any information, data, opinions, advice or statements found on those websites, and NSF does not exert any editorial or other control over those other sites. NSF provides these links merely as a convenience to You and the inclusion of such links does not imply an endorsement by NSF of any such third party sites or their content.
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- Invalidity. If any of the terms and conditions of this Agreement is adjudged to be invalid, void or unenforceable, the remaining terms and conditions of this Agreement will not be affected thereby. Such invalid provision shall automatically be deemed to be replaced by the lawful provision that most nearly embodies the original intention of the parties as expressed herein, and the remaining terms and conditions of this Agreement will in any event otherwise remain valid and enforceable.
- Entire Agreement. This Agreement, its terms and conditions, as well as such other agreements or documents referenced herein, as each may be amended from time to time, constitute the entire agreement between You and NSF with respect to the subject matter of this Agreement and Your use of the Course, and they supersede all previous communications, representations or agreements, whether oral, written or electronic, between the parties with respect to said subject matter. A printed version of this Agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to the terms and conditions of this Agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form.
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