Caused or contributed

Caused or contributed means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:
(1) Failure,
(2) Malfunction,
(3) Improper or inadequate design,
(4) Manufacture,
(5) Labeling, or
(6) User error.


21 CFR § 803.3

Scoping language

Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute . Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part:

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