FDA Transition Plans for Covid EUA Devices
The FDA Announced its Transition Plans for Covid EUA Devices – Gener8’s RND Group has a Solution
The COVID-19 pandemic forced the Department of Health and Human Services (HHS) to declare a public health emergency (PHE). This allowed the Federal Drug Administration (FDA) to issue Emergency Use Authorizations (EUA) for the use of an unapproved product or an unapproved use of an approved product to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological, or nuclear (CBRN) threat agents when there are no adequate, approved, and available alternatives. The FDA has issued approximately 450 device EUAs and 17 medical device enforcement policies. A majority of the device EUAs were for COVID-19 in-vitro diagnostics (IVD) devices. EUAs for those IVD devices were never intended to be permanent. The FDA recently announced the transition guidance to help medical device manufacturers who will be submitting a marketing submission for those devices that were given EUA designation.
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One way we can help is through our FDA Readiness Assessment. We will provide a thorough gap analysis of your processes and product artifacts against required regulations and standards. We will provide actionable recommendations to get you from EUA to a successful marketing submission.
Transition Plans for COVID-19 EUA Devices
On December 22, 2021, The FDA published transition plans for medical devices with EUA designation. The FDA issued two draft guidance documents that outline the proposed process for these transitions:
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (the EUA Transition Draft Guidance)
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (the Enforcement Policy Transition Draft Guidance)
The public may submit comments about the transition plans to the FDA until March 23rd, 2022. The finalized guidance documents will likely retain most of the key policies that are outlined in the drafts of the two documents. These transition plans impact all device manufacturers who currently have products with an EUA designation. Device manufacturers will have to submit a marketing submission to remain on the market.
What Does This Mean for My IVD Device?
There is no clear end date for the COVID-19 public health emergency yet. However, this plan gives manufacturers more insight into the FDA’s intended timelines and policies. The FDA has encouraged device manufacturers with EUA device designation to begin transitioning for more than a year by submitting marketing applications. These draft guidance documents highlight the FDA’s continued push for device manufacturers to plan for the end of COVID-19.
Once the IVD device’s EUA designation expires, marketing authorization will be required to legally remain on the market. The FDA provided the following guidance for IVD manufacturers about termination and transition policies for EUA devices:
FDA will provide an advance notice of termination for each EUA in the US Federal Register 180 days prior to an EUA’s final termination date
FDA will not object to continued marketing of a device for which a premarket application for full US market access has been submitted to the agency by that device’s date of EUA termination
FDA recommends that manufacturers of reusable, life-supporting and life-sustaining devices submit reports to the agency for evaluation of potential product shortages post-EUA termination
IVD manufacturers will be given six months’ notice as a warning to the termination of the EUA period. We suggest submitting a premarket application for full market access now. This time window gives manufacturers the flexibility needed to obtain marketing authorization.
Planning For the Future
Medical device manufacturers should begin to plan their transition sooner rather than later. COVID-19 IVD manufacturers will need to shift their device design from the regulatory requirements of EUA to the regulatory requirements for the applicable marketing submission type. These manufacturers may not have the knowledge and expertise to ensure a successful submission. Thankfully, The RND Group (a Gener8 company) has the capabilities to help IVD manufacturers get from EUA to an accepted marketing submission.
Remember if you want assistance, we can help with our FDA Readiness Assessment.