Field Safety Notice

A field safety notice (FSN) is an important means of communicating a field safety corrective action (FSCA) and related safety information to users. It may also be used to provide updated information about how an IVD should be used.

Manufacturers should inform affected users of an FSCA via an FSN, copying the relevant national regulatory authorities and WHO. The manufacturer should ensure that the FSN is distributed to all affected users and must keep track of confirmation of receipt of the FSN. A full, detailed distribution list with contact name and email address for each intended recipient must be kept and made available on request.

Affected users are will usually receive the FSN via their procurement agents or through in-country distributors who are obliged to inform all users within their region of supply. Distributors may need to translate the FSN from English or another common language to a local language, but this needs to be managed to ensure that the translation is of good quality.

Further purchasing information requirements are specified in the ISO 13485:2016: Medical devices – Quality management systems – Requirements for regulatory purposes.

Content and format of an FSN

The manufacturer should use a standardized format for an FSN (see template below).The FSN should be written on company letter head and in English. It may be translated into the official language(s) of the country by in-country distributors. The FSN should:

  • display a clear title such as "Urgent Field Safety Notice" on the notice itself (i.e. on the envelope if sent by mail and in the subject line if sent by email or fax)
  • clearly indicate the intended recipient of the notice
  • include a concise description of the product, including product code and lot number
  • include a factual statement explaining why the field safety corrective action has been issued, including a description of the problem encountered with the product
  • include a clear description of the hazards associated with the specific failure of the device, and where appropriate, the likelihood of occurrence, taking into account the intended audience
  • describe the recommended action(s) (including recalls) to be taken by the recipient of the FSN, including any action(s) recommended for people that have previously used or been diagnosed through use of the product
  • where appropriate, include timeframes by which the action(s) should be taken by the manufacturer and user(s)
  • give the designated contact point from whom the recipient of the FSN can obtain further information.

Prior consultation with WHO and national regulatory authority(ies) 

It is recommended that manufacturers should provide a draft of the FSN to WHO and the relevant national regulatory authority(ies) (NRAs), allowing a minimum of 48 hours for comment unless the nature of the FSCA dictates a shorter timescale, as in the case of a serious public health threat. If an FSCA is urgently needed because of serious safety risks, prior consultation may not be possible; but such instances are rare. If WHO considers that the FSN does not fully meet requirements, and in particular does not fully explain the risk and/or how it will be removed/reduced, WHO may issue its own information notice and send it to the relevant NRAs for further dissemination to users.

WHO information notices may include recommendations to programmes and implementing partners for alternative testing arrangements and to procurers for past, ongoing or future purchase of affected or potentially-affected products.