Distinguishing Between Medical Device Recalls and Device Enhancements
This guidance applies to medical devices regulated by CDRH to help distinguish between device recalls and device enhancements. It excludes radiation-emitting electronic products, risk management methodologies, and does not address whether new premarket submissions are required.
Recommended Actions
- Establish a process to evaluate device changes and determine if they constitute a recall or enhancement
- For potential recalls, assess:
- If the device is currently marketed
- If there are violations of FDA regulations
- If specifications are not being met
- If labeling is false or misleading
- If there are risks to health
- For recalls:
- Submit 806 report within 10 working days if health risk exists
- Maintain required documentation
- Implement correction or removal actions
- For enhancements:
- Document rationale for enhancement classification
- Maintain records of changes
- Evaluate need for new premarket submissions
- Implement a tracking system for both recalls and enhancements to ensure proper documentation and follow-up
- Train relevant personnel on distinguishing between recalls and enhancements
Key Considerations
Human Factors
- Changes related to ergonomics or usability that affect device safety or performance may constitute a recall if they are linked to violations
Software
- Software changes to address computation errors or failures to perform as represented constitute a recall
- Software updates for enhancement purposes without violations are not recalls
Labelling
- Changes to address false or misleading labeling constitute a recall
- Changes to address inadequate directions for use constitute a recall
- Addition of new warnings to non-violative devices is considered enhancement
Safety
- Changes to address failure to meet specifications or perform as represented constitute a recall
- Increase in failure rates or new failure modes may indicate need for recall
- Changes to improve non-violative device safety are considered enhancements
Other considerations
- Only marketed devices can be recalled
- Changes to undistributed devices are stock recovery, not recalls
- 806 reports must be submitted within 10 working days for recalls that may present health risks
- Records must be maintained for 2 years beyond expected device life
- Market withdrawals for minor violations are not recalls
- Routine servicing and maintenance are not recalls
Relevant Guidances
- Design Controls for Medical Device Manufacturers
- Product Recalls, Removals, and Corrections: Procedures and Best Practices
- Quality System Information Requirements for Premarket Submissions
Related references and norms
- 21 CFR Part 7: Enforcement Policy
- 21 CFR Part 806: Medical Device Reports of Corrections and Removals
- 21 CFR Part 820: Quality System Regulation
Original guidance
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