FDA Hosts Webinar on Draft COVID-19 Medical Device Transition Plans and Improves Tracking of 510(k) Submissions | Wilson Sonsini Goodrich & Rosati

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On February 22, 2022, the United States Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for transition plans for medical devices marketed under emergency use authorization (EUA) or FDA enforcement policies during the coronavirus disease 2019 (COVID-19) public health emergency (COVID-19 PHE). We previously reported on the FDA’s proposed transition plans here. This alert provides an update on FDA communication on the draft guidelines.

The webinar aimed to prepare stakeholders for the transition to normal operations, outline recommendations for submitting a marketing submission, and provide examples to illustrate transition policies and the timeline for the 180-day transition period. FDA reiterated the key principles underlying the draft guidance documents: i) orderly and transparent transition, ii) risk-based approach, iii) necessary FDA oversight to protect public health, and iv) flexibility. continues to ensure patient and healthcare provider access to certain devices. .

The FDA recognizes that the manufacture, distribution, and use of devices in the context of COVID-19 PHE raises unique considerations. Although manufacturers are expected to work towards submitting marketing applications within a specific time frame, the FDA aims to facilitate this process. In determining whether there is reasonable assurance that a device is safe and effective, the FDA is willing to consider real-world evidence and data generated as part of EUA and enforcement policies in subsequent marketing applications. Previous guidance on using real-world evidence to support regulatory decision-making for medical devices can be found here.

Draft EUA Transition Guidelines can be located hereand Draft Transition Guidance for Devices Marketed Under FDA’s COVID-19 Enforcement Policies can be located here. A recording of the webinar will be available for listeners here.

Scope

Although the transition timelines are generally aligned with both transitions, the scope of each orientation differs slightly.

EUA Transitional Scope

FDA’s transition plans apply only to devices with EUA issued based on the COVID-19 EUA statement. The plans do not apply to i) devices with EUA that the FDA has chosen to revoke because the Section 564(c) criteria are no longer met or because other circumstances make such revocation appropriate to protect health or public safety or ii) 564(a) current deviations from good manufacturing practices.

Transitional Scope of Application Policy

FDA’s transition plans apply only to devices that fall under the enforcement policies listed in their draft guidance. The FDA will remove policies from the list as appropriate. Specifically, the “Diagnostic Testing Policy for COVID-19” is outside the scope of this transition plan.

Illustrative examples

The FDA has provided some examples of transition plans.

Sample EUA: A continuous ventilator has been cleared under the EUA umbrella for ventilators, but the device manufacturer has chosen not to pursue marketing clearance.

  • Stage 1: The transition implementation date begins upon publication of a notice of termination of the relevant EUA statement in the Federal Register.
  • Phase 2: The manufacturer submits a notification of intent to inform the FDA that it does not intend to seek marketing authorization.
  • Phase 3: 180 days after the implementation date, the corresponding EUA statement is terminated and the umbrella EUA is no longer in effect. The manufacturer in this example must cease distribution of the device. The FDA, however, has no intention of objecting if that manufacturer develops a plan to keep the already distributed product still distributed.

Sample Application Policy: A new telethermographic system that has not been 510(k) cleared and falls under the application policy for telethermographic systems located here.

  • Stage 1: All manufacturers must continue to comply with requirements that have not been addressed in the enforcement policy, whether or not they intend to distribute their devices beyond the COVID-19 PHE.
  • Phase 2: Recommendations depend on notification of intent for certain life support or life support devices:
    • For a manufacturer that intends to distribute beyond COVID-19 PHE, the FDA recommends that the manufacturer register, list, and submit a marketing submission.
    • For a manufacturer who makes do not intend to distribute beyond 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 makes a final determination on marketing demand. If the manufacturer receives a 510(k) NSE decision after review, the manufacturer must cease distribution and commit to the FDA to process the devices already distributed.
    • For a manufacturer who makes do not intend to distribute beyond COVID-19 PHE, the manufacturer should leave previously distributed products in the field, publicly release revised labeling, send a notice to users, and continue to report adverse events.

Transition timelines

The illustrative examples provided reflect FDA recommendations for action for each phase of the transition:

Chronology Recommendations for action
Stage 1 The 180-day transition period begins on the date of implementation or the date of notice of termination Manufacturers must submit all adverse event reports that have been stored and begin preparing marketing submissions if they intend to continue distribution after the transition period.
Phase 2 Within 90 days of the implementation date Manufacturers must submit a notification of intent for certain life support and life support devices.

For devices that fall under applicable enforcement policies, manufacturers must follow 21 CFR Part 806 (correction and deletion reporting) and Part 807 Subparts BD (registration and listing).

Phase 3 Within 180 days of the start of the transition, EUA statements are terminated and FDA withdraws enforcement policies The FDA expects manufacturers to comply with legal and regulatory requirements applicable to their devices.

Manufacturers must have already submitted FDA-accepted marketing submissions, including transition implementation plans.

FDA Final Action The FDA expects distribution to cease when:
  • Marketing submissions were not accepted during the 180 day transition period
  • Negative decision issued on the marketing submission
  • The manufacturer withdraws its marketing submission or does not provide a complete response to the request for additional information.

The FDA has also provided the following expectations for medical devices related to COVID-19 when distribution is not intended to continue beyond the transition period:

Device type When distribution is not expected to continue beyond the transition period
Single-use, non-life-saving or life-saving devices Can remain distributed and consumed
Reusable, non-vital or vital May remain distributed and used if restored to cleared/approved version, or if publicly available labeling describes functionality and device does not have FDA clearance or approval
Reusable, life sustaining or life sustaining May remain distributed and in use if restored to authorized/approved version, or have both a physical and public copy of labeling describing features and stating that the device does not have the FDA clearance or approval
In vitro diagnostics under EUA May remain distributed for 2 years or until expiration date, whichever is earlier

Submit Comments

The FDA welcomes all comments on the draft transitional guidelines before issuing the final guidelines. The public is invited to submit their comments to the folders until March 23, 2022.

510(k) Submission Tracking

The FDA also recently enhanced its online 510(k) progress tracking tool 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 emphasis on outreach and is a useful tool for managing submission and response times.

Additional questions

The FDA recommends that for scenarios not addressed in the draft guidance, manufacturers should contact the FDA to initiate discussions. Manufacturers are expected to work towards submitting a marketing application within a specific timeframe, and the FDA intends to facilitate this.

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