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I have been doing some research on when to file MDRs. For the most part, the regulation (21 CFR 803) is pretty clear. However, in a guidance document (Medical Device Reporting for Manufacturers) published in 1997 it states:-
A malfunction should be considered reportable if any one of the following is true:-
- it causes the device to fail to perform its essential function and compromises the device's therapeutic, monitoring, or diagnostic effectivenss which could cause or contribute to a death or serious injury, or other significant adverse device experiences.
My questions is, what is meant by a "significant adverse device experience"? Are there any examples?
A malfunction should be considered reportable if any one of the following is true:-
- it causes the device to fail to perform its essential function and compromises the device's therapeutic, monitoring, or diagnostic effectivenss which could cause or contribute to a death or serious injury, or other significant adverse device experiences.
My questions is, what is meant by a "significant adverse device experience"? Are there any examples?