GHTF · International guidance
GHTF/SG2/N57R8:2006
Guidance on Content of Field Safety Notices
International Medical Device Regulators ForumGHTF/IMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- GHTF/IMDRF
- Reference
- GHTF/SG2/N57R8:2006
- Published (source metadata)
- June 27, 2006
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About this guidance
Guidance on Content of Field Safety Notices
Guidance on the required content and format of field safety notices (FSN) for medical device recalls and corrective actions. Ensures consistent communication to users.