Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs
March 24, 2023 - The FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
The FDA encourages stakeholders to review the two final guidances, attend the webinar, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023
Continuous renal replacement therapy (CRRT) devices are used to filter and clean the blood when kidneys are damaged or not functioning normally. Based on published data, it has been noted that SARS-CoV-2, the virus that causes COVID-19, has led to an increased population with critical illness and multiple organ failure, including acute kidney injury, increasing the need for CRRT. Devices authorized by these EUAs include the hemodialyzer/hemofilter, delivery unit, bloodlines and tubing, and dialysate solution.
The table below lists the authorization information for the use of specific CRRT and hemodialysis devices during the COVID-19 public health emergency.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.
|Date EUA Issued||Letter of Authorization||Assigned Product Code||Fact Sheets||Other Documents|
|04/30/2020||Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions||QLP|
|05/20/2020||Baxter Healthcare Corporation, Prismaflex ST Set||QLP|
|08/10/2020||Baxter Healthcare Corporation, Prismaflex HF20 Set||QLP|