This message serves as an update to CSMS # 56244578, focusing on the FDA’s transition plan for medical devices marketed under Emergency Use Authorization (EUA) or enforcement policy during the COVID-19 Pandemic, which was issued on May 12, 2023.
Enforcement Policy Devices within List 1:
Phase 3 of the “Transition Plan for Medical Devices Falling Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” (List 1) is set to commence on November 7, 2023. Manufacturers dealing with List 1 devices are advised to adhere to the following phases:
- Phase 1 commenced on May 11, 2023, enforcing compliance with 21 CFR Part 803 (adverse event reporting requirements).
- Phase 2 began on August 9, 2023, necessitating adherence to 21 CFR Part 806 (reports of corrections and removals requirements) and, for continued distribution post-transition, 21 CFR Part 807 Subparts B-D (registration and listing requirements).
- Phase 3 will begin 180 days after the guidance’s implementation date, namely November 7, 2023. At this stage, enforcement policies outlined in List 1 will no longer be effective. Manufacturers are expected to comply with statutory and regulatory obligations (e.g., 21 CFR Part 801 Subpart B and 21 CFR Part 830), except as mentioned concerning marketing submissions.
Before the onset of Phase 3 (before November 7, 2023), the FDA expects marketing submissions for devices within the guidance’s scope to be submitted and accepted. The submission’s acceptance is crucial for continued distribution post List 1 enforcement policy expiry.
Manufacturers are encouraged to discontinue distribution if they receive a negative decision on their marketing submission as FDA’s final action or fail to provide a complete response within the allotted time.
Enforcement Policy Devices in footnote 11:
Devices listed in footnote 11 are not covered under the phased approach described in the transition plan. For devices aligned with active enforcement policies, filers are advised to use Intended Use Code (IUC) 081.006 during entry filing via ACE.
Emergency Use Authorization (EUA) Devices:
Devices under an active EUA are instructed to use Intended Use Code (IUC) 940.000 during the transition period. Upon EUA termination, submission and acceptance of a marketing submission are expected before continued distribution.
