Field safety notices: guidance for manufacturers
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How to write clear and effective field safety notices (FSNs) for medical devices.
Adapted edition
- Document type
- Reference Guide
- Format
- DOCX
- Pages
- 8
- Language
- English
- Version
- 1.0
- Updated
- 2026-09-16
- Category
- Safety & operations
- Licence
- Open Government Licence v3.0
Description
How to write clear and effective field safety notices (FSNs) for medical devices. Consult the original guidance for current legal and operational details.
Contents
- Good traceability
- FSN content
- Maximising efficacy of FSN communication
- Inclusion of unique device identifiers
- Effective targeting of FSNs and maximising response rates
- The manufacturer's FSCA strategy
- Confidentiality of FSNs
- What the MHRA does when there is an FSCA
- Our FSN review and monitoring process
- Field corrective actions
- Examples of FSCA and FCA
- Examples of field actions considered to be FSCAs
- Example 1
- Example 2
- Example 3
- Example 4
Source and licence
Medicines and Healthcare products Regulatory Agency
AttributionMedicines and Healthcare products Regulatory Agency, ‘Field safety notices: guidance for manufacturers’ (updated 16 June 2025), reused under the Open Government Licence v3.0.
ChangesNeutral text-only adaptation from the official GOV.UK Content API body: headings, paragraphs, ordered and unordered list items and clickable source-link destinations in an appendix preserved. Images, logos, page design, accessible-format request widgets and linked attachments excluded; normalised whitespace, invisible format marks and typography.
Version history
- v1.016/09/2026