As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical facilities equipped with life-saving ventilators.
Ventilator Modification Enforcement Policy
On March 22, 2020, FDA issued a new guidance document, “Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The guidance indicates that FDA will not object to limited, low‑risk modifications of certain ventilator devices, including anesthesia gas machines and other respiratory devices, and their accessories. These modifications can include:
- Hardware changes, such as motors, batteries, and electrical components.
- Modifications to the FDA‑cleared indications, claims, or functionality of ventilators. For example, FDA may allow healthcare facility use of ventilators designed for at-home use, or the use of sleep apnea devices to treat patients with respiratory insufficiency, so long as the proper mitigations are in place.
- Software changes, such as modifying ventilation parameters and implementing the availability of remote monitoring and operation through wireless capability.
- Extension of shelf life. The use of ventilators and gas machine circuit devices beyond their indicated shelf life is also permitted under the new guidance.
FDA requires that modifications based on this guidance follow applicable recognized safety standards, and be described in labeling to help users understand the device’s new indications, functions, and risks. Lastly, the guidance lays out FDA’s intended approach for an Emergency Use Authorization (EUA) of ventilator support devices, encouraging manufacturers with capabilities to increase the supply of these devices to contact FDA to determine if an EUA for such devices can be issued.
By allowing these modifications, FDA seeks to help manufacturers increase manufacturing capacity and supply without prior submission of a premarket notification. An important consequence is that medical facilities will not have to worry about making modifications to complex machinery themselves, but will have some technical and instructional support from manufacturers. This will make it easier and safer for facilities to make the most of machinery that, with a few tweaks, can be pumping oxygen for COVID-19 patients. The guidance emphasizes, however, that healthcare facilities should still continue to use FDA-cleared ventilators, or a device subject to an EUA, whenever possible.
Emergency Use Authorizations
On March 24, 2020, the Secretary of HHS released the declaration necessary for FDA to issue EUAs for ventilators. The declaration states that “circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak.” That same day, FDA kept the promise it made in its March 22 guidance to work with manufacturers of ventilators through the EUA process by issuing an EUA covering ventilators, ventilator tubing connectors, and accessories not currently marketed in the U.S., or for which a modification to the device would typically require submitting a new premarket notification to FDA.
An EUA is essentially an abbreviated approval pathway, available to certain goods only once an authorization is issued for that product category. In order to be included in the list of authorized products in FDA’s ventilator EUA, the sponsor must demonstrate that the product meets the stated criteria for safety, performance, and labeling. Those criteria, set forth throughout the EUA and Appendix A to the EUA, are no breeze. They require the manufacturer to submit:
- Declarations of conformity with various International Electrotechnical Commission (IEC), International Organization for Standardization (ISO), and other safety standards as applicable;
- Product specification and instruction information;
- Shelf-life information and reprocessing information for reusable products;
- Manufacturing facility requirements;
- Labeling information, which includes instructions for use and fact sheets for both healthcare providers and patients, which describe benefits, risks, and available alternatives to the device.
Additional engineering, manufacturing, and labeling considerations apply for ventilator adapters allowing one ventilator to treat multiple patients simultaneously.
FDA will add products to the list after confirming that the applicable safety, performance, and labeling criteria have been met. Once a specific product is authorized, it can be manufactured and distributed without meeting the typical product approval requirements. Authorized products also do not need to comply with current good manufacturing practices for design, manufacture, labeling, storage, and distribution. Nor do sponsors need to follow typical registration and listing requirements for the product. But sponsors do need to maintain records of where they send their devices, notify FDA of their distributors, and report adverse events.
In many ways, these recent actions are consistent with FDA’s COVID-19 strategy to date, which is marked by relaxing typical premarket requirements, capitalizing on existing industry capabilities, and maintaining vigilance on post-market product performance. This allows products to be marketed faster, lets producers retool their manufacturing abilities toward necessary products, and keeps FDA well informed about device performance. On the other hand, the new steps indicate that FDA has shifted its attention to different types of countermeasures. FDA’s production-focused policies to date have mainly addressed low-risk, preventative products like hand sanitizer, N95 respirators, and in-vitro diagnostic products. Ventilators, which are typically viewed as higher risk devices and are often necessary to keep critical patients alive, play a very different role in the battle against COVID-19.