FDA Update: FDA Revokes Umbrella EUA for Infusion Pumps and Accessories

mdi predicated that the FDA would be closing these EUA down as soon as there are enough supply on the market. (https://mdiconsultants.com/life-after-the-eua/)

The FDA monitors the 510(k) activity as we as the importing supply. The FDA has also been contacting companies to determine the amount of supply of various devices.

This is the history of the EUA on Infusion pumps and their accessories:

On May 13 of 2020, the FDA released an umbrella EUA for infusion pump and infusion pump accessories. This was in order to help healthcare providers to treat conditions caused by COVID-19 with a controlled infusion of medications, total parental nutrition, and/or other fluids. Pumps included were those 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 the HCP and the patients with confirmed or suspected of COVID-19.

Several days ago, on September 21, 2020, the FDA has determined that circumstances support the revocation of this umbrella EUA. To this date, there were no device additions to the list of authorized devices in Appendix A of the letter of authorization. The FDA feels 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. This makes it easier to allow for individualized conditions of authorization which allows for ease when addressing unique issues towards a specific device.

In order to view the revocation of the umbrella EUA, please visit the FDA’s website.

We believe the FDA wants to revoke these EUAs as fast as possible so they can get back to regulating the medical device industry and the quality of the devices via the 510(k) process.

If you have any questions about the EUA process and their revocation or are interested in getting your infusion pump authorized for and individualized EUA, please email mdi Consultants at [email protected] RE: Infusion Pump.