Manufacturing and Supply Chain Changes for PMA and HDE Devices During Public Health Emergency
This guidance applies to limited modifications made to devices approved through PMA or HDE programs that would normally require a supplement or 30-day notice submission to FDA. It specifically addresses modifications needed to: - Address component unavailability due to supply chain disruptions - Accommodate manufacturing changes for social distancing - Change manufacturing facilities - Modify packaging procedures
What You Need to Know? 👇
What is the scope of FDA’s enforcement policy for PMA and HDE supplement modifications?
The policy applies to limited modifications addressing manufacturing limitations or supply chain disruptions for PMA and HDE approved devices. It covers component changes, manufacturing procedure adjustments, and site changes that would normally require supplement submission.
Which types of device modifications are excluded from this enforcement policy?
Changes to intended use, new indications, labeling modifications unrelated to manufacturing, sterility assurance level changes, sterilization method changes, quality control testing reductions, and unverified automation processes are excluded from this policy.
How should manufacturers document changes made under this enforcement policy?
Manufacturers must maintain documentation per 21 CFR Part 820, including device master records and change control records. They must verify changes don’t negatively affect safety or performance and include retrospective updates in their next periodic report.
What qualifies as an acceptable alternative manufacturing site under this policy?
Sites must have established GMP history including 21 CFR Part 820 compliance, no concerning FDA inspection observations, no significant recall history, no concerning MDRs, and no regulatory misconduct. Case for Quality VIP participants also qualify.
When did this enforcement policy take effect and does it have an expiration date?
The guidance was issued November 2, 2023, superseding previous COVID-19 related policies. Unlike earlier versions, this policy has no expiration date, though FDA may revise or withdraw it based on ongoing monitoring.
What component and material changes are permitted under this enforcement policy?
Permitted changes include microchip replacements meeting specifications, software/firmware modifications for component changes, hardware changes with components exceeding original specifications, and non-tissue-contacting material changes that meet performance specifications due to supply interruptions.
What You Need to Do 👇
Recommended Actions
- Evaluate if planned modifications fall within scope of guidance
- Document rationale for changes related to manufacturing limitations or supply chain issues
- Implement quality system controls for changes per 21 CFR Part 820
- Verify changes don’t negatively impact safety or performance
- Maintain complete documentation of changes and testing
- For facility changes, verify acceptable GMP history
- Include modifications in next periodic report to FDA
- Monitor FDA updates to this policy
- Ensure changes outside policy scope follow normal supplement submission requirements
Key Considerations
Non-clinical testing
- Manufacturers must verify changes to confirm they don’t negatively affect safety or performance
- Documentation of functional testing may be required
- Documentation of mechanical testing (drop, vibration) may be required
- Documentation of temperature testing may be required
Labelling
- Changes to labeling outside the scope of manufacturing modifications are not covered by this policy
Software
- Software/firmware modifications to accommodate component changes must be documented and verified
- Software changes that don’t impact finished device performance may be allowed
Safety
- Changes must not affect device safety
- Changes to sterility assurance level (SAL) or sterilization method are not covered
- Changes to reduce quality control testing are not covered
Other considerations
- Changes must be performed according to 21 CFR Part 820
- Documentation required in device master record and change control records
- Changes must be reported in next periodic report
- Alternative manufacturing sites must have acceptable GMP history
- Changes to intended use or indications are not covered
Relevant Guidances 🔗
- Quality System Information Requirements for Premarket Submissions
- Manufacturing Site Changes for PMA-Approved Medical Devices: When to Submit a Supplement and Documentation Requirements
- 30-Day Notice Manufacturing Changes for PMA and HDE Approved Devices
- Design Controls for Medical Device Manufacturers
Related references and norms 📂
- ISO 13485: Medical devices - Quality management systems for regulatory purposes