Glossary › Advisory Notice

GLOSSARYGlobal

Advisory Notice

A notice a manufacturer issues after delivery of a medical device to give supplementary information or to advise on the device's use, modification, return to the manufacturer, or destruction.

Where it is written
ISO 13485:2016 clause 3.1; 21 CFR 820.10(b)(4)

Avoid This Mistake

Part 820 sends advisory notices to Part 806: 21 CFR 820.10(b)(4) says they are handled in accordance with that part.

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