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
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.
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||Assigned Product Code||Other Documents|
|04/11/2020||Infusion Pump||B. Braun Space and Outlook Pumps||QOY||
On May 13, 2020, FDA issued an umbrella EUA for infusion pumps and infusion pump accessories for use by healthcare providers (HCPs) to treat conditions caused by the Coronavirus Disease 2019 (COVID-19) with the controlled infusion of medications, total parenteral nutrition (TPN), and/or other fluids. This includes infusion pumps with remote monitoring or remote manual control features or administration sets and other accessories with increased length that help maintain a safe physical distance between HCPs and patients with confirmed or suspected COVID-19 to reduce HCP exposure to the virus that causes COVID-19. To date, however, no device has been added to the list of authorized devices in Appendix A of the letter of authorization.
On September 21, 2020, FDA has determined that circumstances support revocation of the umbrella EUA to protect the public health or safety. Individual EUAs will allow for tailored indications and scopes of authorization, including but not limited to those for different environments of use, routes of administration, and patient populations. In addition, this would allow for individualized conditions of authorization to address any issue unique to a specific device, and more streamlined EUA amendments, such as additional uses that would not fall under this umbrella EUA. Accordingly, FDA has decided to revoke this EUA. Instead, FDA may issue individual EUAs for infusion pumps and infusion pump accessories that meet the requisite EUA statutory criteria.
Accordingly, the EUA was revoked under Section 564(g)(2)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act.