As we enter year three of COVID-19, it may feel like the pandemic may never end. The FDA, however, is seemingly optimistic. On December 23, 2021, the FDA issued two draft guidance documents, which provide transition plans for medical devices authorized by FDA under Emergency Use Authorizations (“EUAs”) and those devices are being commercialized under an enforcement policy issued during the COVID-19 Public Health Emergency (“PHE”). At least for the FDA, a “normal” future is in sight. In the meantime, on January 14, 2022, Department of Health and Human Services Secretary Xavier Becerra renewed the COVID-19 PHE for another 90 days.
Unfortunately, the FDA is not an oracle, and the draft guidance documents provide no assurances as to when we can expect a return to pre-pandemic life. Both transition plans leave room for flexibility that their policies may remain independent of the declared PHE, which deviates from earlier FDA policy. The guidance documents clearly state that EUAs may remain in place after the PHE declaration ends and the FDA Enforcement Policy guidance documents will be withdrawn based on an Agency-determined “implementation date”, associated, but ultimately independent of the PHE declaration. Both draft transition plans follow a similar approach with a 180 day transition. For devices distributed under EUAs, the 180 day clock begins after advance notice of termination of an EUA declaration, published in the Federal Register. There is a phased approach for devices distributed under an Enforcement Policy where Phase 1 starts on an Implementation Date, Phase 2 starts 90 days thereafter, and Phase 3 starts at 180 days and marks the end of the transition period and a return to “normal operations,” i.e., full regulatory compliance. A summary of the transition approach detailed in the two draft guidance documents is provided below.
Once the guidance is finalized for EUA devices, and at the start of Phase 2 for devices in distribution pursuant to an Enforcement Policy, the FDA is asking certain device manufacturers–those with reusable life-supporting or life-sustaining devices–to submit “Notifications of Intent” to detail whether or not they intend to continue distributing their product(s) after the EUA termination date or once the enforcement policy guidance is withdrawn. These “EUA reports”, amendments to existing premarket notifications or PMAs, or cover letters on new marketing submissions will contain: (i) general information (e.g., contact information, place of business); (ii) the EUA request number or title of the enforcement policy guidance; (iii) device identification information (e.g., model numbers); and (iv) whether the manufacturer plans to submit a marketing submission. If the manufacturer is not planning on submit a marketing submission, then the manufacturer will also need to provide details on: (i) its plans to discontinue distribution of the device; (ii) its plans to restore the device to a previously FDA-cleared or -approved version; (iii) updated labeling; and (iv) efforts to mitigate risks of device(s) that remain in distribution after the EUA termination date or once the enforcement policy guidances have been withdrawn.
The Agency is allowing some flexibility for manufacturers to continue distribution of their products while submissions are under consideration by the FDA as long as all other applicable regulatory requirements (e.g., Quality System Regulation (“QSR”) under 21 C.F.R. Part 820, registration and listing under 21 C.F.R. Part 807, and adverse event reporting under 21 C.F.R. Part 803) are met. Labeling will be required to be updated to reflect the product status (e.g., authorized under EUA and now under FDA review). Marketing submissions for devices will also need to include a “transition implementation plan” that will address the manufacturer’s plans for devices already in distribution for both a positive and negative decision on their marketing submission.
For manufacturers that do not intend to continue to distribute their device(s) after the EUA termination date or Phase 3, certain devices may remain in distribution if they meet certain criteria described in the guidance, such as changes to product labeling.
The transition plans feel ambitious for the Agency that is already stretched thin on resources. Although the “Notifications of Intent” is meant to address some of these potential resource constraints, there is a real possibility the Agency may still be overwhelmed with many marketing submissions, sent at the same time, to the same review branches. There is also the question of Q-Submissions, including Pre-Submissions, which are also referenced in the draft transition plans as a mechanism for obtaining Agency feedback on individual transition plans. Currently, with the PHE still in place, the FDA has discouraged or delayed requests through the Pre-Submission process for devices that are unrelated to the COVID-19 pandemic. It remains to be seen how Q-Submissions will be prioritized as the transition plans are finalized.
For device manufacturers, especially non-traditional device manufacturers that stepped in to fill a need during the pandemic, these draft transition plans bring up other unique challenges. Depending on their current level of compliance, the 180 day transition period may be very difficult to achieve. Additionally, manufacturers, even traditional manufacturers, will likely experience resource constraints as they work towards potentially drafting and submitting multiple marketing submissions, all being due at the same time.
Overall, the draft transition plans are malleable. The Agency appears committed to ensuring an orderly transition to “normal operations”, while still providing the appropriate level of oversight and review. The Agency has taken into consideration many of the situations that may arise and intends to make case-by-case compliance and enforcement decisions. That being said, as the Agency begins work on the final version of the draft guidance, device manufacturers should begin the work now to prepare for this transition whether or not they plan to keep their devices on the market.
If you are interested in voicing your opinion, The Agency is accepting comments and suggestions on these draft guidance documents until March 23, 2022.
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