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.
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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PDF Edition — $177
Who Will Benefit
Design Project Managers
Medical device reporting specialists
Field change specialists
Risk Management specialists
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