U.S.FDA Medical Device Reporting Requirements
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
For more information Visit University Website.
Certification / Credits
By completing/passing this course, you will attain the certificate Medical Device Certificate
NSF Health Sciences partners with life science companies, big and small, to provide highly customized end-to-end services throughout the product lifecycle. From early development to commercial manufacture and distribution, our expert services will assist you to: Ensure regulatory compliance Implement...
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