Getting Back to Normal Operations
The FDA recently recommended that “manufacturers of devices authorized under EUA’s (to) plan now, while the pandemic is ongoing, their post-EUA regulatory and disposition strategies.” They are giving guidance on how to transition EUA status for COVID-19 medical devices and transition to normal operations.
Why this recommendation from the FDA?
In looking at the draft guidance, it is clear they want manufacturers of EUA devices “to transition back to normal operations” in advance of the COVID-19 public health emergency policies cease to be in effect. This means that COVID-19 medical devices will require full regulatory approval/review if they are to remain legally commercially available.
Two draft guidance documents were released, which propose a process for transitioning the medical devices brought to market in this manner to full compliance with FDA requirements:
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
The FDA announced that they will now change the EUA status for COVID-19 medical devices and require full regulatory approval/review.
Transition Plan Phases
The transition plan is broken into three phases:1
- Phase 1 begins on the implementation date. The FDA recommends manufacturers follow adverse event reporting requirements under 21 CFR Part 803.
- Phase 2 begins 90 days after the implementation date. Manufacturers should begin complying with 21 CFR Part 806 prior to the start of Phase 2. If they aim to continue distribution of their device after the transition period, they should also begin to follow 21 CFR Part 807 Subparts B-D for registration and listing requirements.
- Phase 3 begins 180 days after the implementation date. The FDA states it intends to revoke the enforcement policy guidance documents listed in the transition plan and that manufacturers “will be expected to comply with all statutory and regulatory requirements applicable to their devices.”
There are several key takeaways that researchers should be aware of as they begin this process to change the EUA status for their COVID-19 medical device. An article written by Goodwin Law summarizes it nicely:
- The transition plan allows for medical device makers 180-days’ notice before terminating EUAs and phasing out its enforcement policies for medical devices that were issued during the COVID-19 pandemic.
- For certain reusable life-supporting or life-sustaining devices, the FDA recommends that manufacturers submit information regarding whether they intend to submit a marketing submission to continue distributing the devices after the EUA Transition Draft Guidance is finalized (for EUA Devices) or before the start of Phase 2 (for Enforcement Policy Devices).
- For devices that a manufacturer decides to not continue distributing after EUA termination, the FDA does not intend to request market removal of certain devices distributed before the EUA termination.
- For devices marketed after EUA termination, the FDA intends to enforce discretion and allow continued distribution of such devices if a marketing submission is accepted by the FDA before the end of the 180-day transition period.
- At the end of the 180-day transition period, the FDA expects manufacturers to comply with other applicable regulatory requirements.
- The FDA expects manufacturers to discontinue distribution of EUA Devices when:
- The manufacturer has not submitted or the manufacturer has submitted but FDA has not accepted a marketing submission for the device prior to the end of the 180-day transition period
- The manufacturer receives a negative decision on its marketing submission
- The manufacturer withdraws its submission or fails to provide a complete response to an FDA request for additional information within the time allotted.
With these draft guidance documents comes many questions. What do you do now? If the transition plans will affect you, it’s important to start planning how to change the EUA status for your COVID-19 your medical device now and begin to make decisions on how you want to move forward.
Compliance is critical so planning should be everyone’s top priority regarding EUA compliance and the eventual transfer to regulated markets.
Partnering with an organization who is familiar with these guidelines can help simplify the transition. At Argonaut we understand manufacturing isn’t easy – especially in life sciences and diagnostics. From new pre-market approval and scale up to ongoing manufacturing our team of experts is here to help you efficiently manufacture the high quality in vitro diagnostic reagents you require.
Learn more about how we can support you at any product stage, here.
Contact us to talk with one of our experts.