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  7. Infusion Pump EUAs
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Infusion Pump EUAs

An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient's body in controlled amounts. The FDA has issued EUAs to help increase the availability of infusion pumps and infusion pump accessories, which are integral to treat patients during the COVID-19 pandemic.

Tables of Infusion Pump EUAs

Manufacturers and other stakeholders may submit a request to the FDA to have their products added to the EUA by emailing CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.


Individual Infusion Pump

The table below includes information about the emergency use of authorized infusion pumps for use during the COVID-19 public health emergency.

Date EUA Issued Device Type Letter of Authorization Fact Sheets Other Documents
04/11/2020 Infusion Pump B. Braun Space and Outlook Pumps
  • None

Umbrella of Infusion Pumps and Infusion Pump Accessories

On May 13, 2020, the FDA issued an EUA for infusion pumps and infusion pump accessories that among other things, meet certain safety, performance, and labeling criteria, in response to concerns relating to the insufficient supply and availability of the devices for use by healthcare providers in the continuous infusion of medications, total parenteral nutrition, and/or other fluids into patients during the COVID-19 pandemic. This includes infusion pumps with remote monitoring or remote manual control features or administration sets and other accessories with increased length that help to maintain a safe physical distance between healthcare providers and patients with or suspected of having COVID-19 to reduce healthcare provider exposure. Infusion pumps and accessories that have been confirmed by the FDA to meet the criteria are included in Appendix A below.

A manufacturer may request the addition of any eligible infusion pump and/or infusion pump accessory to Appendix A by submitting a request to CDRH-COVID19-InfusionPumps@fda.hhs.gov, as outlined in the EUA.A manufacturer may request the addition of any eligible infusion pump and/or infusion pump accessory to Appendix A by submitting a request to CDRH-COVID19-InfusionPumps@fda.hhs.gov, as outlined in the EUA.

Appendix A: Authorized Infusion Pumps and Infusion Pump Accessories

This table will include information about the authorized infusion pump or infusion pumps accessories authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.

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