Transition Plan for Medical Devices Distributed Under COVID-19 Emergency Enforcement Policies
This guidance outlines FDA's transition plan for medical devices that were distributed under enforcement policies issued during the COVID-19 public health emergency (PHE). It applies to devices falling within enforcement policies described in 17 specific guidances (List 1) and aims to provide an orderly transition from emergency policies to normal operations after the PHE expires.
What You Need to Know? 👇
What is the timeline for the FDA’s transition plan for COVID-19 enforcement policy devices?
The transition plan has three phases starting May 11, 2023: Phase 1 (0 days) requires adverse event reporting compliance; Phase 2 (90 days) requires registration/listing and correction/removal reporting; Phase 3 (180 days) ends enforcement policies, requiring accepted marketing submissions for continued distribution.
Which devices are covered under the COVID-19 enforcement policy transition guidance?
The guidance applies to devices covered by 16 specific enforcement policies listed in “List 1,” including remote digital pathology devices, imaging systems, fetal monitoring devices, telethermographic systems, psychiatric digital health devices, ECMO systems, ventilators, PPE, sterilizers, and infusion pumps.
What happens to devices already distributed if manufacturers don’t submit marketing applications?
For single-use non-life-supporting devices, they can be used until expiration. Reusable non-life-supporting devices must be restored to FDA-cleared versions or have updated labeling. Life-supporting/sustaining devices must be restored to cleared versions or labeled as unauthorized and not used.
What is required in the “Transition Implementation Plan” for marketing submissions?
The plan must include estimated numbers of distributed devices, benefit-risk disposition plans for negative decisions, notification processes for stakeholders, restoration timelines, labeling update procedures, maintenance plans, and plans for addressing devices after positive decisions including regulatory status updates.
Can manufacturers continue distributing devices while FDA reviews their marketing submissions?
Yes, FDA won’t object to continued distribution if the marketing submission is accepted before Phase 3 starts and no final action is taken. However, manufacturers must comply with all other requirements except certain UDI and labeling requirements during review.
What are the quality system requirements during the transition period?
Manufacturers must comply with 21 CFR Part 820 quality system requirements throughout all phases. Non-traditional manufacturers facing compliance challenges may request exemptions or variances within 90 days of the implementation date announcement, and FDA will consider unique circumstances case-by-case.
What You Need to Do 👇
Recommended Actions
- Begin compliance with adverse event reporting requirements immediately if not already doing so
- Before Phase 2 (90 days after implementation):
- Register establishments and list devices
- Implement correction and removal reporting
- Submit Notification of Intent for applicable life-supporting devices
- Begin preparing marketing submissions
- Before Phase 3 (180 days after implementation):
- Submit and have marketing submission accepted by FDA
- Include Transition Implementation Plan with submission
- Ensure compliance with all applicable regulatory requirements
- After Phase 3:
- Ensure full compliance with all applicable regulations
- Update labeling as required
- Implement Transition Implementation Plan based on FDA decision
- Cease distribution if marketing submission not accepted or receives negative decision
- Throughout transition:
- Maintain communication with stakeholders
- Monitor and comply with applicable quality system requirements
- Keep records of distributed devices
- Follow applicable adverse event reporting requirements
Key Considerations
Labelling
- Devices must be labeled as described in the relevant List 1 guidance while under FDA review
- Updated labeling required after marketing authorization that accurately describes product features and regulatory status
- For reusable life-supporting/life-sustaining devices, stakeholders should be provided opportunity to request physical copy of updated labeling without additional cost
Safety
- Manufacturers must comply with adverse event reporting requirements under 21 CFR Part 803
- Must follow correction and removal requirements under 21 CFR Part 806
- Quality System requirements under 21 CFR Part 820 must be met
Other considerations
- Manufacturers must register establishments and list devices under 21 CFR Part 807 Subparts B-D
- Marketing submissions must be submitted and accepted by FDA before Phase 3 to continue distribution
- Transition Implementation Plan required with marketing submissions
- Special notification requirements for certain life-supporting/life-sustaining devices
- 180-day transition period divided into 3 phases
Relevant Guidances 🔗
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Quality System Information Requirements for Premarket Submissions
- Distinguishing Between Medical Device Recalls and Device Enhancements
- Device Labeling Requirements and Content for Premarket Approval Applications
Related references and norms 📂
- 21 CFR Part 803: Medical Device Reporting
- 21 CFR Part 806: 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