Last November 8, the FDA issued the final version of the guidance “Medical Device Reporting for Manufacturers”.
Goal of this guidance is to assist medical device Manufacturers in the application of regulatory requirements by reporting adverse events and to allow FDA and immediate action. Furthermore, some of the most common reporting errors are listed and detailed.
At the end and after 20 years (the previous version was issued in 1997), FDA clarifies, explains and comments again the requirements of the 21 CFR 803.
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