Today, the U.S. Food and Drug Administration (FDA) issued an immediately in effect guidance, Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, that provides regulatory flexibility for manufacturers of certain FDA-cleared infusion pumps and accessories to help expand the availability of these products.
This guidance is intended to help ensure health care providers can maintain an adequate supply of devices for patients who require continuous infusion of medications, nutrition, and/or other fluids and help foster technologies that maintain a safer physical distance between the health care provider and the patient, such as adding remote capabilities. The devices include large volume parenteral (LVP) infusion pumps, syringe infusion pumps, patient-controlled analgesic (PCA) infusion pumps, and ambulatory infusion pump devices, and their accessories.
The guidance outlines an approach for certain modifications to the indications, functionality, hardware, software, design or materials of these devices without submission of a new 510(k).
This policy reflects the FDA’s commitment to ease burdens on health care providers and facilities as they face the COVID-19 public health emergency.