Amid reported shortages of ventilators, accessories, and other respiratory devices resulting from the spread of novel coronavirus COVID-19, FDA issued a letter to health care providers and new guidance on 22 March 2020, related to FDA’s policies intended to increase access to devices for providing respiratory support. The guidance provides leeway to manufacturers of breathing support devices to allow use of these products for broader indications and also suggests that Emergency Use Authorizations (EUAs) may be granted to allow ventilators which are not currently FDA-cleared into clinical care environments. Further, the guidance supports the EUA pathway for manufacturers who do not traditionally manufacture medical equipment but may be able to partner with ventilator companies to manufacture such devices.
Summary of FDA's guidance and proposed approach to enforcement
FDA emphasizes throughout the letter to health care providers and guidance that whenever possible, heath care facilities should use FDA-cleared ventilators within the scope of their clearance to treat patients who develop respiratory failure or respiratory insufficiency. However, recognizing the critical need for more ventilators, the guidance outlines several pathways to increasing the supply of devices which can provide breathing support.
Initially, where ventilators may be in short supply, FDA indicates that physicians and hospitals should look to other devices which are FDA-cleared and are capable of delivering respiratory support. FDA states that the agency does not “intend to object” to manufacturers of FDA-cleared devices modifying the indications, claims, or making minor modifications to the functionality, hardware, software, or materials of devices in order to support patients with respiratory failure or respiratory insufficiency, without prior submission of a 510(k) notice, during the duration of the declared public health emergency. Specifically, FDA cited examples of situations in which more flexibility could be applied, either in the uses for which certain products are marketed or used and/or the materials being used in manufacture. For instance, FDA suggests that ventilators cleared only for short term use could be used for longer durations or that using CPAP machines or BiPAP machines to treat patients with respiratory insufficiency could be appropriate when certain design mitigations are incorporated.
FDA also indicated that adding certain functional capabilities to existing cleared devices may not be seen as creating an undue risk in light of the public health emergency. FDA cited examples such as the introduction of filtration to minimize aerosolization, software modifications to allow ventilation parameter modifications (such as inspiratory pressure, tidal volumes, flow rates, and positive end-expiratory pressure), and modifications to allow for remote monitoring and adjustment of ventilator parameters.
FDA also noted that the agency would not object to changes in the indicated shelf life and duration of use for other ancillary devices, such as the tubing that connects the ventilator to the patient, filters, and humidifiers for the duration of the health emergency, even without prior submission of a 510(k) notice, so long as the change does not create an undue risk in light of the public health emergency.
In instances where a company believes that a device can be used to provide ventilatory support, FDA encouraged companies to provide labeling with any updated instructions, indications, claims, or functions, as well as risks and differences between FDA-cleared and non-cleared uses.
Potential use of EUA pathway
Finally, in what could be a significant change in the agency’s position of recent weeks, this guidance suggests that the Emergency Use Authorization (EUA) pathway may be available to address ventilators which are not currently cleared for use in the U.S. The guidance contemplates two types of manufacturers for whom the EUA pathway could be considered: (1) manufacturers of ventilators which have previously been cleared or approved by other jurisdictions outside of the US; and (2) manufacturers who do not manufacture medical devices but are able to assist in increasing the supply of such products.
FDA indicates that companies falling into either of these categories, and also domestic manufacturers of new ventilators, should contact FDA and provide specific information about such devices and how the devices could be shown to meet appropriate manufacturing and testing standards. The guidance further outlines the information being sought from these types of entities wishing to distribute or manufacture ventilators. Inquiries related to all new ventilators and manufacturing capabilities should be sent to the following address: CDRH-COVID19-Ventilators@fda.hhs.gov At this point, it is unclear how FDA will work with the manufacturing companies seeking to product ventilators and/or what FDA will do with this information.
What this means for manufacturers and other companies seeking to manufacture ventilators
The guidance offers significant avenues for increasing capacity and supply of devices to provide respiratory support to hospital systems in the US. The guidance relaxes several standard regulatory paradigms, including off-label promotion of cleared devices as well as the addition of contract manufacturers and critical component suppliers who may not comply with the Quality System Regulation (QSR). Companies should carefully review this new FDA guidance and engage with FDA to ensure they remain with the confines of FDA’s enforcement discretion policies.
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