FDA Eases Enforcement to Help Make More Ventilators Available

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The U.S. Food and Drug Administration (the “FDA”) issued Guidance[1] on March 22, 2020 to continue its efforts to maintain an adequate supply of devices to treat patients who develop respiratory failure or respiratory insufficiency. The agency intends to exercise enforcement discretion relating to certain modifications of FDA-cleared devices and use of these devices beyond their intended environment or shelf life.  

The Guidance applies to respiratory devices and their accessories, which include ventilators, anesthesia gas machines, and others.[2]  Under the Guidance it is clear that health care facilities should use FDA-cleared conventional/standard full featured ventilators when necessary to support patients with respiratory failure.  However, the FDA does not intend to object to 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.  In essence, the FDA is being more flexible with its requirement for premarket review for these modified devices.

Not every modification to or modified use of the prior FDA-cleared medical devices will escape scrutiny or review from the FDA.  Rather, only those alterations or modifications “where the modification will not create an undue risk in light of the public health emergency” will be subject to the FDA’s enforcement discretion. This language is less than black and white and leaves many questions unanswered. To assist in this regard, the Guidance provides examples which the FDA currently believes do not create undue risk as well as recommendations for labeling of these modified devices.  

Examples of the types of modifications that the FDA currently believes do not create a risk include:

• Use of devices outside of their intended environment (e.g., using a sleep apnea device intended for home use in a hospital setting);
• Certain modifications to the devices, such as:
  • Changes to the power source;
  • Changes to components (such as hoses);
  • Changes to the software;
  • Changes to the hardware and/or software to allow for remote monitoring or remote adjustment.
• Use of the devices or their components beyond indicated shelf life.

These devices must still be safe for use.  Indeed, the Guidance explains that devices used outside of their intended environment should be altered and/or monitored to ensure they are safe to properly support patients with respiratory failure or respiratory insufficiency.  Software modifications should properly implement cybersecurity controls to assure device cybersecurity and maintain device functionality and safety.  Devices used beyond their indicated shelf life should only be used if there are no device malfunctions or visible soiling. 

In addition, the modified devices should include labeling that will help the users better understand how the device was modified and how to properly use the devices based on the modifications. These labels should clearly delineate what indications or claims are FDA-cleared and those that are not FDA-cleared.

Suppliers and manufacturers of respiratory devices looking for alternative ways to increase production or to assist in equipment modification and those interested in entering the field should review the Guidance in its entirety. We, of course, can assist with clearance of modifications or communicating with the FDA.

The COVID-19 crisis is obviously a fluid situation generating a multitude of issues on a daily basis. Seyfarth Shaw regulatory attorneys are closely monitoring the situation around the clock. We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our Resource Center for more information.

 

[1] The Guidance represents the FDA’s current thinking on this topic and does not establish any rights or responsibilities for any person.  It is not binding on the FDA or the public.  Indeed, the Guidance makes clear that it is intended to remain in effect only during the COVID-19 public health emergency declared by the Department of Health and Human Services and any renewals.

[2] A full list devices can be found in the Guidance at Table 1.