The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement policies to obtaining permanent marketing authorization.
As the May 11 end of the COVID-19 Public Health Emergency (PHE) approaches, the US Food and Drug Administration (FDA) finalized on March 27, 2023 two guidance documents which establish a framework for transitioning “medical devices that were issued emergency use authorizations (EUAs) or fall within certain enforcement policies issued to support the response to the Coronavirus Disease 2019 (COVID-19) pandemic”:
FDA’s latest action is in response to the feedback and public comments the agency received to the draft guidance documents which, as we previously wrote, were issued in December 2021. Through these final transition guidance documents, FDA provides recommendations and clarity for medical device manufacturers that either intend to continue marketing their devices or wish to discontinue distribution after the relevant EUA declaration or the enforcement policies are no longer in effect.
Key takeaways found in the two guidance documents include the following:
EUA DEVICES SUBJECT TO EUA TRANSITION GUIDANCE
- Consistent with the draft guidance document:
- Manufacturers will have 180 days to submit a marketing application (e.g., 510(k)) once Health and Human Services (HHS) publishes a notice of termination of its authority provided under Section 564 of the Federal Food, Drug, and Cosmetic Act (FFDCA) to issue EUAs (the EUA Termination Date).
- HHS has not provided any indication as to when it will publish a notice of termination and recently affirmed [1] that it will continue its emergency use authority under Section 564 even though the PHE declared under Section 319 of the Public Health Service (PHS) Act will expire at the end of the day on May 11, 2023.
- Two product codes, QOF and QQX, have been established that allow COVID-19 test developers to obtain 510(k) clearance of their assays. To the extent the product codes do not cover an assay’s intended use/technology, FDA is open to accepting De Novo submissions in which to authorize the assay.
- After the 180 days, a manufacturer may continue to market its device while the application is pending, provided that FDA accepted the application for substantive review (i.e., cleared “Refuse to Accept”) prior to the end of the 180-day period.
- With the exception noted below concerning labeling and Unique Device Identification (UDI), after the 180 days manufacturers will need to comply with the general controls of the FFDCA, including the Quality System Regulation (QSR), Medical Device Reporting (MDR), and establishment registration and device listing requirements.
- In a somewhat surprising move, FDA clarified that it would treat COVID-19 laboratory developed tests (LDTs) after the EUA Termination Date like any other LDT (FDA has required that COVID-19 LDTs obtain an EUA). This means that FDA will extend enforcement discretion for compliance with the FFDCA for such LDTs rather than require permanent marketing authorization.
- FDA removed its draft guidance recommendations for interim labeling and UDI requirements for devices that had been authorized under an EUA while a marketing application is pending.
- FDA provided guidance for how it intends to quickly CLIA-categorize (e.g., moderate, waived) in vitro diagnostics once permanent marketing authorization is obtained. Specifically, categorization will be based on the authorized environment established in the EUA.
ENFORCEMENT DISCRETION DEVICES SUBJECT TO ENFORCEMENT POLICY TRANSITION GUIDANCE
- FDA set the start date of the transition period for devices marketed under a COVID-19 enforcement policy as May 11, 2023, the date the PHE expires. Consistent with the draft guidance document, manufacturers will have 180 days (i.e., until November 7, 2023) to transition out from the enforcement discretion. As of November 7, 2023, the enforcement policies will not be in effect. The impacted policies are provided in List 1 of the Enforcement Policy Transition Guidance.
- Consistent with the draft guidance document, FDA kept the original three-phase transition plan, providing new dates for each phase:
- Phase 1 – Begins on May 11, 2023. Manufacturers must ensure they follow the MDR requirements.
- Phase 2 – Begins on August 9, 2023. Manufacturers must ensure they follow the corrections and removals reporting requirements, as well as the registration and listing requirements.
- Phase 3 – November 7, 2023. FDA will withdraw the enforcement policies and manufacturers will be expected to comply with all general controls applicable to their devices, including the QSR, labeling, and UDI requirements.
- Importantly, and unchanged from the draft guidance, manufacturers that do not wish to seek clearance of their reusable devices that have been marketed under the enforcement discretion are required to either (1) restore the device to its cleared/authorized version; (2) withdraw the device from the field; or (3) update the labeling of the device in the field to reflect the regulatory status of the product features (i.e., certain features lack FDA clearance, approval, or authorization).
- Withdrawing the devices from the field or applying the updated labeling to the products in the field will likely constitute a correction/removal that requires evaluation for reporting to FDA per 21 C.F.R. Part 806.
NEXT STEPS
In both final guidance documents, FDA reiterated that device manufacturers planning to seek marketing authorization for their devices covered by either the EUA Transition Guidance or the Enforcement Policy Transition Guidance should begin working on their marketing submissions, including their transition implementation plans, as soon as possible.
Considering the expected rush to submit marketing applications closer to the end of the relevant 180-day period, manufacturers that submit their applications sooner will be better positioned for an earlier decision from FDA.
[1] See Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap | HHS.gov.
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