FDA Eases Enforcement for Infusion Pumps, Electronic Thermometers During COVID-19 Pandemic
The Food and Drug Administration recently issued two new documents detailing its enforcement policies for infusion pumps and electronic thermometers during the COVID-19 pandemic. The agency’s April 4 enforcement policy for electronic thermometers allows distribution of devices that are not…
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510(k) cleared under certain conditions. The enforcement policy for infusion pumps, issued April 5, allows “manufacturers that make device modifications to address manufacturing limitations or supply shortages related to the public health emergency,” FDA said.