- August 11, 2020
The move is similar to a previous Agency authorization issued in late March that broadly covered ventilators and respiratory devices, in a bid to quickly expand their supply against the pandemic. That policy allowed alternative or modified devices to be used for ventilation, such as anesthesia gas machines, as long as they met certain criteria. Manufacturers could then request to have their product added to a list of FDA-authorized devices.
The newer authorization includes pumps and accessories used to deliver certain medications — such as Gilead’s remdesivir, which currently requires an intravenous infusion, though the company is working on an inhaled formulation of the antiviral — as well as certain devices for providing liquid nutrition and other fluids.
The Agency also highlighted infusion pumps that feature remote control or monitoring features, or even wired accessories with long cords, that would allow healthcare providers to keep a safer distance from the patient and reduce their potential exposure to the novel coronavirus. And while the umbrella authorization covers various IV administration sets, containers and catheters — as well as patient-controlled pumps for delivering painkillers — it does not include insulin pumps or closed-loop systems. Enteral feeding pumps and elastomeric infusion pumps that use a pressurized balloon to deliver medication are also not eligible.
REFERENCE: Fierce BioTech; 15 MAY 2020; Conor Hale