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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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PDF Edition
Available Format
PDF Edition — $177
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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