FDA aims to thwart infusion pump shortage with new industrywide emergency use authorization
Featuring George Gray, CTO Ivenix: MedTechDive, May 15, 2020
- FDA said Thursday it issued an emergency use authorization to spur availability of infusion pumps as the lifesaving machines and accessories are in short supply for COVID-19 patients.
- The agency in early April issued guidance targeted at increasing access to breathing devices for patients who may require continuous infusion of medications, nutrition, and other fluids. But this week’s EUA takes the effort a step farther by allowing the manufacture, distribution, and use of pumps and accessories not otherwise cleared or approved for sale, or that require a modification that would ordinarily prompt a new premarket notification to FDA.
- The EUA in part covers infusion pumps with remote monitoring, remote manual control features, administration sets and other accessories with increased length designed to help maintain a “safe physical distance” between healthcare professionals and COVID-19 patients.
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