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.
What You Need to Know? 👇
What is the key difference between a medical device recall and a device enhancement?
The key difference is the existence of a violation. A recall addresses devices that violate FDA laws or regulations, while an enhancement improves a non-violative device’s performance, quality, or user experience without correcting any regulatory violations.
When must manufacturers submit an 806 report to FDA for device corrections or removals?
An 806 report must be submitted within 10 working days when a correction or removal is initiated to reduce health risks or remedy violations that may present health risks, unless already reported under other regulations.
Does improving device performance from specifications always constitute a recall?
No. If a device meets its represented specifications and the improvement exceeds those specifications without addressing violations, it’s considered an enhancement. Only changes addressing failure to meet represented performance constitute recalls.
What regulatory submissions might be required for device enhancements?
Device enhancements may require premarket submissions under 21 CFR 807.81(a)(3) for 510(k) devices or 814.39 for PMA devices, depending on the nature and significance of the changes made to the device.
How does FDA distinguish between routine servicing and a device recall?
Routine servicing involves regularly scheduled maintenance, calibration, or normal wear replacement. Recalls involve unexpected repairs, early part replacement, or identical repairs across multiple units indicating device violations or performance failures.
What documentation requirements exist for corrections and removals not requiring FDA reporting?
Manufacturers must maintain records of all corrections and removals for two years beyond the device’s expected life, even after ceasing manufacturing. Records must transfer to new owners and include details per 21 CFR 806.20.
What You Need to Do 👇
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