On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization (EUA) or the FDA's Enforcement Policies during the Coronavirus Disease 2019 (COVID-19) public health emergency (COVID-19 PHE). We previously reported on the transition plans proposed by the FDA here. This alert provides an update to FDA communication on the draft guidance(s).
The webinar sought to prepare stakeholders for transition to normal operations, describe recommendations for submitting marketing submission, and provide examples to illustrate transition policies and the 180-day transition period timeline. The FDA reiterated key principles underlying the draft guidance documents: i) orderly, transparent transition, ii) risk-based approach, iii) necessary FDA oversight to protect public health, and iv) continued flexibility to ensure patient and healthcare provider access to certain devices.
The FDA acknowledges that the manufacture, distribution, and use of devices in the context of the COVID-19 PHE raises unique considerations. Although manufacturers are expected to work towards submission of marketing applications on a specific timeline, the FDA aims to facilitate this process. In determining whether there is a reasonable assurance that a device is safe and effective, the FDA is willing to consider real-world evidence and real-world data generated under the EUA and enforcement policies in subsequent marketing applications. Past guidance on Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices can be found here.
The draft transition guidance for EUAs can be located here, and the draft transition guidance for devices commercialized under the FDA's COVID-19 Enforcement Policies can be located here. A recording of the webinar will be available for listeners here.
Scope
While the transitional timelines are generally aligned across both transitions, the scope of each guidance differs slightly.
EUA Transitional Scope
The FDA's transitional plans only apply to devices with EUAs issued on the basis of the COVID-19 EUA declaration. The plans do not apply to i) devices with EUAs that the FDA chose to revoke because the Section 564(c) criteria are no longer met or because other circumstances make such revocation appropriate to protect the public health or safety or ii) 564(a) current good manufacturing practice deviations.
Enforcement Policy Transitional Scope
The FDA's transitional plans only apply to devices that fall within the enforcement policies listed in their draft guidance. The FDA will remove policies from the list as appropriate. Specifically, the “Policy for Diagnostic Tests for COVID-19” falls outside of the scope of this transitional plan.
Illustrative Examples
The FDA provided a couple of examples of transitional plans.
EUA Example: A continuous ventilator was authorized under the umbrella EUA for ventilators, but the device manufacturer chooses not to pursue marketing authorization.
- Phase 1: Transition implementation date begins upon publication of advance notice of termination of the relevant EUA declaration in the Federal Register.
- Phase 2: The manufacturer submits a Notification of Intent to inform the FDA that it does not intend to pursue a marketing authorization.
- Phase 3: 180 days after the implementation date, the relevant EUA declaration is terminated and the umbrella EUA is no longer in effect. The manufacturer in this example must cease distribution of the device. The FDA does not intend to object, however, if this manufacturer develops a plan for already distributed product to remain distributed.
Enforcement Policy Example: A new telethermographic system that was not 510(k)-cleared and falls within the Enforcement Policy for Telethermographic Systems located here.
- Phase 1: All manufacturers must continue to comply with the requirements that were not addressed in the enforcement policy, regardless of whether they intend to distribute their devices beyond the COVID-19 PHE.
- Phase 2: Recommendations depend on notification of intent for certain life supporting or life sustaining devices:
- For a manufacturer who intends to distribute beyond the COVID-19 PHE, the FDA recommends that the manufacturer registers and lists and submits a marketing submission.
- For a manufacturer who does not intend to distribute beyond the COVID-19 PHE, the FDA expects the manufacturer to cease distribution, notify users of regulatory status, and continue to report adverse events.
- Phase 3: 180 days after implementation, the guidance document is withdrawn:
- For a manufacturer who intends to distribute beyond the COVID-19 PHE, the FDA does not intend to object to continued distribution until the FDA takes a final action on the marketing submission. If the manufacturer receives a 510(k) NSE decision after review, the manufacturer must cease distribution and engage with the FDA to address already-distributed devices.
- For a manufacturer who does not intend to distribute beyond the COVID-19 PHE, the manufacturer is expected to leave previously distributed in the field, make revised labeling public available, send notice to users, and continue to report adverse events.
Transitional Timelines
The illustrative examples provided reflect FDA action recommendations for each phase of the transition:
| |
Timeline |
Action Recommendations |
| Phase 1 |
180-day transition period begins on implementation date or date of advance notice of termination |
Manufacturers should submit any adverse event reports that were stored, and begin to prepare marketing submissions if they intend to continue distribution after the transition period. |
| Phase 2 |
Within 90-days after implementation date |
Manufacturers should submit Notification of Intent for certain life supporting and life sustaining devices.
For devices that fall within applicable enforcement policies, manufacturers should follow 21 CFR Part 806 (reports of corrections and removals) and Part 807 Subparts B-D (registration and listing).
|
| Phase 3 |
Within 180-days after the transition begins, EUA declarations are terminated and the FDA withdraws enforcement policies |
The FDA expects manufacturers to comply with statutory and regulatory requirements applicable to their devices.
Manufactures should have already submitted marketing submissions which are accepted by the FDA, including Transition Implementation Plans.
|
| Final FDA Action |
The FDA expects distribution to cease when:
- Marketing submissions were not accepted within 180-day transition period
- Negative decision issued on marketing submission
- Manufacturer withdraws marketing submission or fails to provide complete response to request for additional information.
|
The FDA also provided the following expectations for COVID-19 related medical devices when distribution is not intended to continue beyond the transition period:
| Device Type |
When Distribution is Not Intended to Continue Beyond Transition Period |
| Single-use devices, non-life supporting or life sustaining |
May remain distributed and consumed |
| Reusable, non-life supporting or life sustaining |
May remain distributed and used if they are restored to cleared/approved version, or have labeling publicly available that describes features and that device lacks FDA clearance or approval |
| Reusable, life supporting or life sustaining |
May remain distributed and used if they are restored to cleared/approved version, or have both publicly available and physical copy of labeling that describes features and that the device lacks FDA clearance or approval |
| In Vitro Diagnostics under EUA |
May remain distributed for 2 years or until the expiration date, whichever is less |
Submitting Comments
The FDA welcomes all comments on the draft transition guidance before they publish final guidance. The public is welcome to submit comments to the dockets until March 23, 2022.
510(k) Submission Tracker
The FDA also recently enhanced its online 510(k) progress tracker to capture Special and Abbreviated 510(k)s in addition to the pre-existing Traditional 510(k) tracking capability. The update to include Special and Abbreviated 510(k) submissions is consistent with the FDA's focus on outreach and is a useful tool to manage submission and response deadlines.
Additional Questions
The FDA recommends that for scenarios that are not addressed in the draft guidances, manufacturers should reach out to the FDA to initiate discussions. Manufacturers are expected to work toward submission of a marketing application on a specific timeline, and the FDA intends to help facilitate this.
