Blood Purification 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
Blood purification devices may be effective at treating certain patients with confirmed COVID-19 by reducing various pathogens, cytokines, and other inflammatory mediators, that is, small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient. The proteins that are removed are typically elevated during infections and can be associated with a “cytokine storm” that may occur in some COVID-19 patients, potentially leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.
The table below lists the authorization information for the use of specific blood purification 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|
|04/09/2020||Terumo BCT Inc. and Marker Therapeutics AG Extracorporeal Blood Purification (EBP) Devices||QLO|
|04/10/2020||CytoSorbents, Inc. Extracorporeal Blood Purification (EBP) Device||QLO|
|04/17/2020||ExThera Medical Corporation Extracorporeal Blood Purification (EBP) Device||QLO|
|04/22/2020||Baxter Healthcare Corporation Extracorporeal Blood Purification (EBP) Device||QLO|