Transition Plan for Medical Devices with COVID-19 Emergency Use Authorization After Declaration Termination
This guidance applies to medical devices that have been issued an Emergency Use Authorization (EUA) under section 564 of the FD&C Act related to COVID-19. It outlines the transition plan and requirements when the EUA declarations are terminated. The guidance does not apply to devices for which FDA has already revoked the EUA or to current good manufacturing practice deviations authorized under section 564A(c).
Recommended Actions
- Determine whether to continue device distribution after EUA termination
- If continuing distribution:
- Submit marketing submission before EUA termination
- Include Transition Implementation Plan
- Maintain compliance with EUA conditions until termination
- Consider CLIA requirements for IVDs
- If discontinuing distribution:
- Cease distribution by EUA termination date
- Update labeling for reusable devices
- Communicate plans to stakeholders
- Continue adverse event reporting
- For reusable life-supporting devices:
- Submit Notification of Intent
- Restore to FDA-cleared/approved version or provide updated labeling
- Ensure labeling accessibility
- Review and plan for Quality System compliance
- Document transition plans and maintain records
- Engage with FDA early for any unique considerations through Q-Submission Program
- Monitor FDA communications regarding EUA termination dates
Key Considerations
Labelling
- For devices continuing distribution after EUA termination: maintain EUA labeling while marketing submission is under FDA review
- For devices discontinuing distribution: provide updated labeling that accurately describes product features and regulatory status for reusable devices
- For reusable life-supporting/life-sustaining devices: provide physical and/or electronic copy of updated labeling without additional cost upon request
Safety
- Continue adverse event reporting per 21 CFR Part 803 requirements even after cessation of distribution
- Address any safety issues identified during FDA review through corrections or removals as needed
Other considerations
- Submit “Notifications of Intent” for certain reusable life-supporting/life-sustaining devices
- Include a “Transition Implementation Plan” in marketing submissions
- For IVDs: address CLIA categorization and waiver considerations
- Quality System compliance expectations will be considered on case-by-case basis
- Submit marketing submissions with sufficient time for FDA acceptance before EUA termination
- Cease distribution on EUA termination date if no accepted marketing submission
- Communicate transition plans to stakeholders (distributors, healthcare facilities, providers, patients)
Relevant Guidances
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Emergency Use Authorization of Medical Products: Requirements and Procedures for Unapproved Products and Uses
Related references and norms
- 21 CFR Part 803: Medical Device Reporting
- 21 CFR Part 806: Medical Devices; Reports of Corrections and Removals
- 21 CFR Part 807: Establishment Registration and Device Listing
- 21 CFR Part 820: Quality System Regulation
- 21 CFR Part 801: Labeling
Original guidance
- Transition Plan for Medical Devices with COVID-19 Emergency Use Authorization After Declaration Termination
- HTML / PDF
- Issue date: 2023-03-27
- Last changed date: 2023-03-24
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket, Coronavirus, Postmarket
- ReguVirta summary file ID: c8bbfc4a499d0b47346611d49a99cca7
This post is licensed under CC BY 4.0 by the author.