Question of the Month with Comment
MedSun: Newsletter #8, October 2006

Question:
How long must hospitals retain copies of MedSun or MedWatch reports submitted to the FDA?

Comment:
From FDA: Per 21 CFR Part 803.18(c), if you are a user facility, you must retain a medical device reporting (MDR) event file relating to an adverse event for a period of 2 years from the date of the event. If you are a manufacturer or importer, you must retain an MDR event file relating to an adverse event for a period of 2 years from the date of the event or a period of time equivalent to the expected life of the device, whichever is greater. If the device is no longer distributed, you still must maintain MDR event files for the time periods described in this paragraph.


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