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Medical Device Reporting (MDR) 21 CFR Part 803 1 Objectives Review applicable sections of 21 CFR 803 and 21 CFR 820 Review and explain MDR reporting requirements Review FDA-483 observation examples
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What is 21 cfr part 803?
21 CFR Part 803 is a regulation that outlines the requirements for medical device reporting (MDR) in the United States.
Who is required to file 21 cfr part 803?
Manufacturers, importers, and user facilities of medical devices are required to file 21 CFR Part 803.
How to fill out 21 cfr part 803?
21 CFR Part 803 can be filled out online through the FDA's Electronic Submission Gateway (ESG) or by submitting a paper form directly to the FDA.
What is the purpose of 21 cfr part 803?
The purpose of 21 CFR Part 803 is to ensure the safety and effectiveness of medical devices by requiring the reporting of certain adverse events and product problems.
What information must be reported on 21 cfr part 803?
Information such as device malfunctions, serious injuries, and deaths related to the use of medical devices must be reported on 21 CFR Part 803.
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