The new article highlights the aspects related to the special framework allowing face masks intended for a medical purpose to be placed on the market under a simplified procedure.
Table of Contents
Introduction
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the enforcement policy for face masks and barrier face coverings in the context of Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus”. The document outlines the approach the authority intends to apply in order to ensure and expand the availability of the said products during the COVID-19 outbreak and public health emergency associated thereto. In particular, the guidance describes temporary and extraordinary measures the authority intends to introduce.
It is also important to mention that provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarification regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with existing legislation and has been agreed with the authority in advance.
EUAs for Face Masks: Key Points
First of all, the authority mentions that face masks intended to be used by healthcare professionals and laypersons as source control are covered by the scope of the respective emergency use authorization (EUA). It is stated that the said authorization is intended to increase the availability of such devices in light of the increasing demand.
Conditions for authorization to be applied with respect to such face masks are aligned with section 564 of the FD&C Act. The authority explicitly states that the final decision on granting authorization will be taken on a case-by-case basis. However, general criteria would still apply. According to the guidance, the said conditions include, inter alia, the following ones:
- Appropriate conditions designed to ensure that healthcare providers (HCP) administering the device are informed
- That FDA has authorized the emergency use of the device;
- Of the significant known and potential benefits and risks of the emergency use of the device, and of the extent to which such benefit and risks are unknown; and
- Of the alternatives to the device that are available, and of their benefits and risks.
- Appropriate conditions designed to ensure that individuals to whom the device is administered are informed
- That FDA has authorized the emergency use of the device;
- Of the significant known and potential benefits and risks of the emergency use of the device, and of the extent to which such benefit and risks are unknown; and
- Of the option to accept or refuse administration of the device, of the consequence, if any, of refusing administration of the device, and of the alternatives to the device that are available and of their benefits and risks.
- Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the device. In this respect, the authority mentions that the requirements to be applied are in line with provisions of regulation 21 CFR Part 803.
- For manufacturers of the device, appropriate conditions concerning record keeping and reporting, including records access by FDA, with respect to emergency use of the device.
Summary
The new policy described in detail in the present guidance document is intended to introduce a special framework ensuring the uninterrupted availability of vitally important products during the pandemic, and face masks and barrier face coverings are among them. These products are falling outside the scope of the existing classification rules for medical devices, even though they are intended to be used for medical purposes and are subject to regulation as medical devices. Face masks and barrier face coverings described in the guidance are covered by product codes QKR and QOZ respectively.
The authority emphasizes that face masks described in the guidance should not be used as personal protective equipment since they are not providing the necessary level of protection. Instead, these products should be used for source control.
It is also important to mention that the regulatory approach addressed in the guidance will not apply to such products as:
- Humidifier, respiratory mask;
- Mask, anesthetic, gas;
- Resuscitator, manual, non-self-inflating;
- Mask, ventilator, non-continuous, reprocessed;
- Strap, head, gas mask.
In summary, the present FDA guidance describes in detail specific criteria to be applied when determining whether face masks are eligible for placement on the market under the emergency use authorization framework. The guidance provides clarifications regarding the conditions to be met, including the ones related to the scope of information to be duly communicated to the parties using the product in question (such as healthcare professionals or the general public).
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