Emergency Use Authorization and Enforcement
FDA Response to COVID-19 – Ventilators
Under the current emergency, supply chain for ventilators that meet FDA regulatory requirements have been substantially stressed, with shortages already observed in the US. Ventilators are an integral part of routine patient care and are critical for care of patients with severe respiratory distress. Providing regulatory flexibility for ventilators, ventilator tubing connectors, and ventilator accessories, FDA aims to meet the needs of the US healthcare system.
Working with manufacturers, the FDA is currently working toward expanding availability of ventilators to be used by those requiring use due to COVID-19. 46 EUAs for ventilators have been issued since March 25, 2020. Candidate ventilators (and ventilator tubing connectors, and ventilator accessories) are those currently not marketed in the US, or currently cleared devices that have undergone significant changes. Significant changes include modifications to design, material, chemical composition, energy source, or manufacturing process.
In issuing a letter of authorization, the FDA has provided a detailed list of device specific requirements for EUA request in Appendix A. General information, identified above, is to be submitted via email. Ventilator tubing splitters have specific conditions for authorization issued in the letter.
As with decontaminated respirators, the FDA has released requirements for “authorized labeling”. Authorized labeling for ventilators under the EUA provides information to both HCPs and patients. Instructions for use, a Fact Sheet for HCPs, and Fact Sheet for Patients regarding emergency use of ventilators during the COVID-19 pandemic must accompany ventilators, ventilator tubing connectors and ventilator accessories listed under the EUA.
Under the conditions of authorization all device labeling requirements remain in place except UDI (21 CFR 830, 21 CFR 801.20), and should not represent or suggest that the device is safe or effective in prevention or treatment of COVID-19. Adverse event reporting requirements remain in place and records associated with the EUA should be maintained and made available to the FDA for inspection upon request. Any distribution of ventilators, ventilator tubing connectors, and ventilator accessories should be recorded with the number of devices and specific location of distribution.
NOTE: At time of publication, three (3) additional devices related to ventilators have received EUA’s separate from the ventilator list. Two devices are Diaphragmatic Pacing Therapy Systems (DPTS) to assist in weaning patients off intubated ventilators. Neuromuscular stimulation of the diaphragm for patients on long terms mechanical ventilation may improve natural breathing and potentially stop dependence on a mechanical ventilator. The third is an extracorporeal CO2 scrubber that allows use of lower pressure ventilation and weaning off intubated ventilators as well.
Ventilator Enforcement Discretion
Modifications to ventilators, anesthesia gas machines, and other respiratory devices and accessories are subject to eased enforcement from the FDA. FDA does not intend to object to limited changes to indications, claims, functionality, hardware, software, or materials of FDA-cleared devices used to support respiratory insufficiency or failure. Where once changes may trigger the submission of a 510(k), no premarket notification will be required. Changes to the indications, such as environment for use, will not be objected to, e.g. an at-home ventilator in use in a healthcare setting.
To address supply chain disruptions and achieve the need for patients requiring respiratory support, changes to hardware, software, and materials will not require a premarket notification where there is no undue risk created. This included adding hardware or software capabilities to support remote monitoring of devices, such as wireless or Bluetooth capabilities.
In making changes, it is still expected to do so in accordance with recognized standards for the specific device type. Manufacturers must document changes to their device in their device master record and change control records and make this information available to the FDA for inspection upon request. Labeling requirements still apply, and it is expected that labeling will be updated to help users better understand the device modifications. Any changes to the indications or claims are to be accompanied by information on device performance and potential risk. Instructions for use highlighting the design change from the FDA-cleared device and a clear delineation of FDA-cleared instructions and claims to those not FDA-cleared.