The FDA today temporarily loosened its enforcement on ventilators and some related devices to address manufacturing limitations and supply shortages during the coronavirus pandemic.

The agency issued a temporary guidance that also covers certain anesthesia machines, respirators, oxygen conservers and delivery devices for hospital or home use. The guidance describes a limited number of modifications to the indications, claims, function, hardware, software or materials of FDA-cleared devices for patients with respiratory failure or insufficiency. It will remain in effect until the end of the public health emergency.

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