FDA Issues Enforcement Policy for Ventilators and Other Respirators

The Enforcement Policy can be found here. This Policy remains in effect only for the duration of the COVID-19 public health emergency.

FDA does not intend to object to certain modifications to the indications, claims, functionality, hardware or software, or materials of certain FDA-cleared devices without the prior submission of a new premarket notification (“510(k)”) for those modifications. The types of eligible devices are listed on p. 6 of the Policy.

For all permitted changes, FDA recommends that the product labeling include:

1.  A clear description of the device’s new indications, claims, or functions, and information on its performance and potential risks;
2. Adequate instructions for use and indicated environment(s) of use;
3. Clear delineation between FDA-cleared and non-cleared indications and claims.

The types of changes that are permitted under this new Policy include the following:

Modifications to FDA-Cleared Indications, Claims, or Function

1. The use of powered emergency ventilators and anesthesia gas machines for patients needing mechanical ventilation;
2. The use of ventilators outside their cleared environment of use (e.g., use in a health care facility when it is only cleared for use at home)
3. Use of devices intended for sleep apnea (e.g., CPAP or BiPAP) provided that certain design mitigations are in place to minimize aerosolization;
4. Use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.

Hardware, Software, and Material Changes to FDA-cleared Ventilators and Anesthesia Gas Machines

1. Modifications to motors, batteries, or other electric components;
2. Material changes to components in the gas pathway or with other patient tissue contact;
3. Introduction of filtration to minimize aerosolization
4. Software modifications intended to modify the ventilation parameters;
5. Software modifications implementing automated algorithms for oxygen titration where the algorithms/devise are the subject of an FDA-approved IDE
6. Hardware and/or software modifications implementing the capability for remote monitoring and adjustment o ventilator parameters

To support the claims or indications above, FDA has also announced that it does not intend to object to modifications to allow for increased remote monitoring and setting adjustment capability/availability (e.g., addition of wireless and/or Bluetooth capability). Any such changes should include appropriate cybersecurity controls. The guidances that FDA recommends firms use in making those design changes are listed on p. 9 of the Policy.

Use of Ventilator and Gas Machine Breathing Circuit Devices Beyond Shelf Life and Duration of Use

Examples of covered constituent parts are listed on p. 9, and include various types of tubing, filters, and humidifiers. FDA does not intend to object to changes in the indicated shelf life or duration of use of these products for treating individual patients where such change would not create an undue risk.  Such circumstances include where the devices are used according to healthcare institutional protocols, or useful life is limited to the occurrence of a malfunction or visible soiling.

Validation of Changes Made

The list of FDA recognized standards that are recommended to be used in the design, evaluation, and validation of changes made to hardware, software, materials or duration of use are listed on p. 10-11 of the Policy.

EUAs for Ventilatory Support Devices

On March 24, FDA issued an Emergency Use Authorization (EUA) for certain ventilators, anesthesia gas machines and positive pressure breathing devices for use as ventilators, ventilator tubing connects and accessories. The letter of authorization covering this EUA can be found here, and the devices eligible for Authorization under that EUA are listed on pp. 3 and 4. Once an EUA is granted, the specific devices and manufacturer. will be listed in Appendix B.

FDA is interested in hearing from other manufacturers of ventilator support devices that are not currently legally marketed in the US, as well as manufacturers who have not been previously engaged in medical device manufacturing. FDA intends to work with those manufacturers through its Emergency Use Authorization (EUA) process. Any interested manufacturer should contact FDA via CDRH-COVID19-Ventilators@fda.hhs.gov with the information listed on pp. 12-14 of the Policy.