FDA Relaxes Ventilator Oversight in Effort to Boost Supply

The U.S. Food and Drug Administration (FDA) has taken significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.
 
“The FDA’s new actions will mean America can make more ventilators during this crisis,” said U.S. Health and Human Services Secretary Alex Azar. “The actions are another step by the FDA and HHS to eliminate every possible barrier to the all-of-America approach that President Trump has called for. With this boost from the FDA, medical device makers can more easily make changes to existing products, such as changes to suppliers or materials, to help address current manufacturing limitations or supply shortages. Other manufacturers, such as auto makers, can more easily repurpose production lines to help increase supply. Hospitals and other health care providers can repurpose machines they have now to serve as ventilators. HHS and FDA’s message is clear: If you want to help expand production of ventilators to save American lives in this pandemic, we are going to work with you to sweep every possible barrier out of your way.”
 
“The FDA is doing everything we can to support patients, health care professionals, hospitals, medical product manufacturers and the public during this pandemic. One of the most impactful steps we can take is to help with access and availability to life-saving medical treatments,” said FDA Commissioner Stephen Hahn, M.D. “Our policy issued today demonstrates our ability to react and adapt quickly during this pandemic and help very ill patients access the lifesaving ventilator support they need. To do that, we are providing maximum regulatory flexibility to facilitate an increase in ventilator inventory, while still providing crucial FDA oversight. We believe this action will immediately increase ventilator availability. We will continue to engage with both traditional medical device manufacturers and other manufacturers about ways we can facilitate a ramping up of production of these life-saving medical devices.”
 
The guidance issued on March 22 outlines several key steps.
 
First, the guidance describes the agency’s intention to exercise enforcement discretion for certain modifications to these FDA-cleared devices. Normally, any time a manufacturer or user makes a modification to a ventilator device, for instance, adding wireless and/or Bluetooth capability for remote monitoring, those modifications can often trigger an FDA premarket review, which can delay the time it takes to get these devices to the bedside. The guidance also helps manufacturers ramp up their manufacturing by adding production lines or alternative sites, for instance, using non-medical device manufacturers such as automobile manufacturers, to start manufacturing ventilator parts. In recognition of the current pandemic situation, and to ease regulatory burden on manufacturers, the FDA is being flexible in not enforcing the premarket review requirement for these modifications.
 
Second, as outlined in this guidance, hospitals and health care professionals may use ventilators intended for other environments. For example, the guidance notes hospitals that could repurpose ventilators normally used for transporting patients in an ambulance into the hospital setting for long-term use. The FDA also provides recommendations for other alternatives that should be considered such as devices for treating sleep apnea, continuous positive airway pressure (CPAP), devices.
 
The FDA’s policy also applies to health care facilities that use ventilators beyond their indicated shelf life, which should increase ventilator capacity.
 
Finally, the agency encourages manufacturers, whether foreign or domestic, to talk to FDA about pursuing an emergency use authorization (EUA), which would allow them to distribute their ventilators in the United States. This includes U.S.-based manufacturers that were previously engaged in making medical devices, but which have capabilities to increase supply of these devices.
 
Taken altogether, these actions as outlined in the guidance demonstrates the FDA’s flexibility during this pandemic to help manufacturers and encourage increased production of ventilators.
 
This guidance is one of many actions the FDA has taken to increase the availability of medical devices, including diagnostic supplies and personal protective equipment (PPE).
 
The FDA is responding to questions from diagnostic laboratories about the availability of certain testing supplies. The agency is updating in real time frequently asked questions from labs and test developers, providing information on alternative sources of reagents, extraction kits, swabs and more. The toll-free line, 1-888-INFO-FDA, is in place to help laboratories with any questions they may have about the EUA process or getting supplies.
 
The FDA has been working closely with PPE manufacturers to understand their supply capabilities during this pandemic. The agency is also aware of challenges throughout the supply chain that are presently impacting the availability of PPE products and is taking steps to mitigate shortages that health care facilities are already experiencing. For example, on March 2, the FDA granted an Emergency Use Authorization to allow NIOSH-approved respirators typically used in industrial settings to be used in health care settings. The agency has also published a Letter to Healthcare Providers and FAQs that provide conservation strategies for gowns and masks and continues to coordinate and communicate with interagency and state partners to help ensure that they are more readily available.
 
On Friday, the agency also issued a Letter to Health Care Providers sharing conservation strategies for surgical gloves, recognizing the need for PPE, such as medical gloves, may outpace the supply available to health care organizations during the COVID-19 pandemic. Proposed conservation strategies include using nonsterile disposable patient examination gloves for routine patient care or using medical gloves beyond the manufacturer-designated shelf life in a setting where there is a lower risk of transmission.
 
The FDA is working around the clock to monitor and mitigate emerging coronavirus issues through collaborative efforts with federal partners, international regulators, and medical product developers and manufacturers to help advance response efforts to combat the COVID-19 pandemic.