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FSCAs & Recalls

What is an FSCA?​

A Field Safety Corrective Action (FSCA) is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with a medical device that is already on the market. FSCAs may include:

  • Device recalls (return to manufacturer)
  • Device modifications or upgrades
  • Labelling or instructions changes
  • Advisory notices to users or healthcare professionals

When an FSCA is required​

An FSCA should be initiated when the manufacturer becomes aware of a safety issue that requires action to reduce risk to patients, users, or other persons. This may result from:

  • Adverse event reports received from the market
  • Internal quality system findings
  • Post-market clinical data or literature
  • Regulatory authority instructions

Notifying Roszdravnadzor​

Before executing an FSCA in Russia, the manufacturer (or RUS REP) must notify Roszdravnadzor. The notification should include:

  • Description of the safety issue
  • Affected devices (model, lot numbers, registration certificate number)
  • Proposed corrective action
  • Timeline for execution
  • Field Safety Notice (FSN) intended for users and healthcare facilities

Field Safety Notices (FSNs)​

A Field Safety Notice (FSN) is the written communication sent to users, healthcare facilities, and distributors informing them of the safety issue and the corrective action required. FSNs must be:

  • In Russian (for distribution in Russia)
  • Clear and actionable
  • Sent to all known affected users

RZN-initiated safety actions​

Roszdravnadzor has the authority to order mandatory recalls or safety actions where it determines a device presents an unacceptable risk and the manufacturer has not taken appropriate action. RZN can also suspend or cancel a Registration Certificate in serious cases.

Official source

Roszdravnadzor: roszdravnadzor.gov.ru