Posted: 31 Mar 2020 12:36 AM PDT
By Adrienne R. Lenz, Senior Medical Device Regulation Expert —
You’ve seen the news about insufficient supply and availability of ventilators to treat patients with Coronavirus Disease 2019 (COVID-19). You’ve also likely seen news of ideas to mitigate this shortage. On March 24, 2020 FDA issued an Emergency Use Authorizations (EUA) for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as “ventilators”), ventilator tubing connectors, and ventilator accessories (EUA) and a companion policy, Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Policy) to allow emergency use of ventilators in healthcare settings. Eligible devices include “ventilators, ventilator tubing connectors and ventilator accessories that are not currently marketed in the U.S., or that are currently marketed in the U.S., but a modification is made to the device that would trigger the requirement that a manufacture submit a new premarket notification (510(k)) to FDA.” Policy at 3.
Instead of an EUA for a specific device, FDA has issued a general EUA that provides criteria for specific devices to be added. Eligible devices will be added to Appendix B of the EUA after FDA determines they meet the criteria for safety, performance and labeling set forth in Appendix A of the EUA. With the EUA, FDA will waive requirements for current good manufacturing practices (cGMP) and registration and listing.
For devices that are currently cleared in the US and will be modified for emergency use, the Policy states that the Agency does not intend to object to introduction of these modifications without submission of a premarket notification (510(k)). Three types of modifications are discussed.
For manufacturers who have not previously been engaged in medical device manufacturing but with capabilities to increase supply of these devices, FDA states that they intend to work collaboratively through the EUA process. The Policy notes that this applies to US manufacturers in other manufacturing sectors.
To be added to Appendix B of the EUA, devices must be validated to ensure safety and performance and accompanied by EUA labeling. The criteria for safety, performance and labeling requirements are specified in Appendix A of the EUA. The Policy as well as Appendix A of the Ventilator EUA require safety and performance standards be complied with, as applicable. These standards cover basic safety and essential performance, electromagnetic compatibility, use in the home, software lifecycles, wireless coexistence, biocompatibility, and device specific performance. Instead of submission of test reports, the EUA request should include declarations of conformity to these standards. The EUA also should include: device specifications, instructions, reprocessing and shelf-life information, facility requirements (e.g., gas connection type). For continuous ventilator splitters (adapters for multiplexing), safety and performance considerations for creating and testing these components are provided, including material properties, gas pathway biocompatibility, leak, disconnect alarm and compliance with standards for ventilator circuitry.
Finally, the EUA provides labeling considerations for both ventilators and ventilator splitters. For ventilators, labeling will include specifications, alarms, reprocessing and other applicable instructions, a statement that FDA has authorized emergency use of the device and FDA’s fact sheets, Fact Sheet for Healthcare Providers and Fact Sheet for Patients. Additional recommendations are provided for the safe use of ventilator splitters.
There are currently no devices listed in Appendix B of the EUA. Even with the waivers provided by the EUA, there could be significant delays to bring additional ventilators to the market if all of the required testing has not been previously conducted. It is not clear if FDA will add devices to Appendix B that have some basis of safety and performance data, while allowing some tests to be run concurrently with distribution and use of the devices to meet emergency demand. The Policy is clear that the Agency understands the need and intends to collaborate with manufacturers. Engaging them early, by contacting CDRH-COVID19-Ventilators@fda.
You’ve seen the news about insufficient supply and availability of ventilators to treat patients with Coronavirus Disease 2019 (COVID-19). You’ve also likely seen news of ideas to mitigate this shortage. On March 24, 2020 FDA issued an Emergency Use Authorizations (EUA) for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as “ventilators”), ventilator tubing connectors, and ventilator accessories (EUA) and a companion policy, Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Policy) to allow emergency use of ventilators in healthcare settings. Eligible devices include “ventilators, ventilator tubing connectors and ventilator accessories that are not currently marketed in the U.S., or that are currently marketed in the U.S., but a modification is made to the device that would trigger the requirement that a manufacture submit a new premarket notification (510(k)) to FDA.” Policy at 3.
Instead of an EUA for a specific device, FDA has issued a general EUA that provides criteria for specific devices to be added. Eligible devices will be added to Appendix B of the EUA after FDA determines they meet the criteria for safety, performance and labeling set forth in Appendix A of the EUA. With the EUA, FDA will waive requirements for current good manufacturing practices (cGMP) and registration and listing.
For devices that are currently cleared in the US and will be modified for emergency use, the Policy states that the Agency does not intend to object to introduction of these modifications without submission of a premarket notification (510(k)). Three types of modifications are discussed.
- Modifications to the indications for use, claims or functionality, such as the use of powered emergency ventilators and anesthesia gas machines for mechanical ventilation of patients, use of ventilators outside of their cleared environment of use, use of sleep apnea devices and oxygen concentrators when medically necessary and clinically appropriate.
- Modifications to hardware, software and materials changes to allow use of alternative components, addition of filtration, modification of ventilator parameters and remote monitoring. FDA will also not object to implementation of technology currently authorized under an Investigational Device Exemption that provides physiological closed loop (automate) algorithms for oxygen titration.
- Use of breathing circuit components beyond their indicated shelf-life and duration of use.
For manufacturers who have not previously been engaged in medical device manufacturing but with capabilities to increase supply of these devices, FDA states that they intend to work collaboratively through the EUA process. The Policy notes that this applies to US manufacturers in other manufacturing sectors.
To be added to Appendix B of the EUA, devices must be validated to ensure safety and performance and accompanied by EUA labeling. The criteria for safety, performance and labeling requirements are specified in Appendix A of the EUA. The Policy as well as Appendix A of the Ventilator EUA require safety and performance standards be complied with, as applicable. These standards cover basic safety and essential performance, electromagnetic compatibility, use in the home, software lifecycles, wireless coexistence, biocompatibility, and device specific performance. Instead of submission of test reports, the EUA request should include declarations of conformity to these standards. The EUA also should include: device specifications, instructions, reprocessing and shelf-life information, facility requirements (e.g., gas connection type). For continuous ventilator splitters (adapters for multiplexing), safety and performance considerations for creating and testing these components are provided, including material properties, gas pathway biocompatibility, leak, disconnect alarm and compliance with standards for ventilator circuitry.
Finally, the EUA provides labeling considerations for both ventilators and ventilator splitters. For ventilators, labeling will include specifications, alarms, reprocessing and other applicable instructions, a statement that FDA has authorized emergency use of the device and FDA’s fact sheets, Fact Sheet for Healthcare Providers and Fact Sheet for Patients. Additional recommendations are provided for the safe use of ventilator splitters.
There are currently no devices listed in Appendix B of the EUA. Even with the waivers provided by the EUA, there could be significant delays to bring additional ventilators to the market if all of the required testing has not been previously conducted. It is not clear if FDA will add devices to Appendix B that have some basis of safety and performance data, while allowing some tests to be run concurrently with distribution and use of the devices to meet emergency demand. The Policy is clear that the Agency understands the need and intends to collaborate with manufacturers. Engaging them early, by contacting CDRH-COVID19-Ventilators@fda.
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