Advisory notice

ISO 13485 uses this term for what the EU calls a field safety notice and FDA handles under corrections and removals. The quality system needs a procedure for issuing advisory notices, and the standard expects them to be possible at any time, not only during a recall.

notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the: — use of a medical device, — modification of a medical device, — return of the medical device to the organization that supplied it, or — destruction of a medical device Note 1 to entry: Issuance of an advisory notice can be required to comply with applicable regulatory requirements.

ISO 13485:2016, clause 3.1