On March 22, 2020, the FDA released guidance describing an enforcement policy that will help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic. FDA’s guidance would permit “limited modifications to the indications, claims, functionality, or to the hardware, software, or materials of FDA-cleared devices used to support patients with respiratory failure or respiratory insufficiency, without prior submission of premarket notification under section 510(k)” of the Food, Drug & Cosmetic Act. Examples of permitted modifications include adding wireless and/or Bluetooth capability for remote monitoring. FDA’s guidance would also permit use of ventilators intended for other settings, such as ventilators used in transportation, in the acute care setting. FDA also indicated that “alternative devices capable of delivering breaths or pressure support” (e.g., CPAP, BiPAP) should be considered to extend and prioritize the availability of ventilators. The FDA states that the purpose of the guidance is to “help ensure the availability of the greatest possible number of devices” for patients with respiratory failure. The policy will provide additional flexibility to manufacturers to address current limitations or supply shortages. This enforcement policy will remain in place for the duration of the public health emergency related to COVID-19. Additional guidance may be found here.
The Health Law Pulse will continue to provide updates as more is known about this public health crisis.