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Corrections, Removals and Recalls: A Guide for Devicemakers

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Corrections, Removals and Recalls
A Guide for Devicemakers

You have a tangled web of rules, interpretations, issues and actions that make it difficult to know how to proceed when you make a change to one of your medical devices.

You need to have clear definitions of key terms — correction, removal, recall, stock recovery, market withdrawal…

You’re looking for guidance on deciding whether you need to report the action you take to the FDA.

The Corrections, Removals and Recalls: A Guide for Devicemakers brief sorts it all out for you, defining the key terms and parsing the FDA regulations that govern corrections, removals and recalls.

You’ll learn:

  • Why there are two separate regulations — Part 7 and Part 806 — you need to be aware of and how they differ
  • Where the FDA draws the line between a product correction and a product enhancement
  • When and how to report your action to the FDA and how the agency decides if the action you have taken should be considered a recall
  • How the FDA classifies recalls
  • How the agency expects you to protect the security of your cyber-connected devices

BONUS: You’ll receive a decision-making tool to help you identify whether you need to file a report with the FDA or just keep your own internal records.

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Who Will Benefit

  • Quality Assurance
  • Design Engineers
  • Design Project Managers
  • Regulatory Affairs
  • Legal counsel
  • Complaints specialists
  • Medical device reporting specialists
  • Field change specialists
  • Risk Management specialists

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