April 21, 2023
Devices distributed under enforcement discretion during the COVID-19 pandemic are subject to transition planning beginning May 11, 2023
On March 27, the Food and Drug Administration released its final guidance outlining the 180-day transition plan for medical devices that were distributed under enforcement discretion policies during the COVID-19 pandemic. Now, in addition to a closely related EUA Transition Plan, FDA is introducing a three-phase plan that will allow devices already distributed under pandemic-era enforcement discretion policies to continue to be legally marketed.
As part of pandemic efforts to increase the availability of certain medical devices, FDA supported enforcement discretion policies for items such as sterilizers, disinfectants, air purifiers, in vitro diagnostics, surgical masks, remote monitoring devices, respirators, and ventilators that could aid in the treatment and prevention of COVID-19. The phased transition plan described in the March 27 guidance is structured to give manufacturers time to decide whether they intend to continue to market and distribute medical devices distributed under enforcement discretion, complete a marketing submission where applicable, and comply with adverse event reporting requirements under regular FDA operations.
To support device makers, FDA hosted a webinar to discuss the Enforcement Discretion Transition Plan as well as the EUA Transition Plan April 18, 2023. Materials from that webinar are now available through CDRH Learn, under "Specialty Technical Topics," "COVID-19 Transition Policy."
FDA's Three-Phase Plan
Phase 1 of the Enforcement Policy Transition Plan will begin when the public health emergency declaration expires May 11, 2023. During this time, manufacturers should begin complying with 21 CFR Part 803 (i.e., adverse event reporting requirements).
Phase 2 will begin 90 days later, August 9, 2023, with companies required to also meet 21 CFR Part 806 relating to reports of corrections and removals to FDA. In addition, FDA expects that marketing applications will be submitted to the agency and accepted for review before Phase 3, which starts November 7, 2023. For those manufacturers who intend to continue to distribute their devices beyond this phase, they should also follow registration and listing requirements.
Phase 3 will begin 180 days after the implementation of this guidance, at which time none of the enforcement policy guidance documents included in List 1 of the transition plan will be in effect. During this transition period, while marketing submissions are still pending, FDA may continue to exercise enforcement discretion for certain other regulatory requirements. When FDA has taken final action on a device's marketing submission, the manufacturer must comply with all applicable requirements.
Given the number of devices being marketed under FDA's temporary enforcement policies, it is likely many companies will require assistance within a relatively limited timeframe to plan and execute strategies aimed at assuring QMS compliance, perform appropriate testing, support formal meetings with FDA, and prepare pre-market submissions. As such, medical device companies may be well served by identifying required transition activities now and planning to add resources appropriately where necessary.
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