Serious adverse health consequences

Serious adverse health consequences means any significant adverse experience related to a device, including device-related events that are life-threatening or that involve permanent or long-term injuries or illnesses.

Source

21 CFR § 822.3

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Scoping language

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

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