The new article describes in detail the regulatory policy to be applied with respect to certain medical devices used in the context of the pandemic.
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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 covering used during the outbreak of Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus” and public health emergency associated thereto. The document provides an overview of the temporary and extraordinary measures introduced by the FDA in order to ensure and expand the availability of the said products during the pandemic to meet the increased demand. 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 clarifications 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 the existing legislation and has been agreed with the authority in advance.
Face Masks Not Intended for a Medical Purpose
First of all, the document describes the regulatory approach to be applied with respect to face masks that are not intended for medical purpose. Under the general rule, face masks falling within the scope of medical device definition set forth under the FD&C Act are considered medical devices and, consequently, should be subject to regulation under the medical devices framework. At the same time, there are other masks available on the market, intended for other purposes. The authority additionally emphasizes that such masks would not require its authorization, while the provisions of the FD&C Act would not apply to the parties involved in operations with them.
The authority further explained that face masks are considered medical devices in case they are initially intended for a medical purpose – for instance, prevention of infectious disease transmission. According to the guidance, when assessing the product in terms of its regulatory nature, the authority will consider whether:
- They are labeled or otherwise intended for use by HCP;
- They are labeled or otherwise for use in a healthcare facility or environment; and
- They include any drug, biologics, or anti-microbial/anti-viral agents.
Products Not Intended to Provide Liquid Barrier Protection
The scope of the guidance also covers the aspects related to face masks and barrier face coverings intended for medical purpose that is not intended to provide liquid barrier protection.
The authority emphasizes the importance of using personal protective equipment (PPE) for the personnel involved in healthcare operations during the pandemic. In particular, it is stated that healthcare employers must comply with Occupational Safety and Health Administration standards that required PPE to protect workers and that apply to infectious disease hazards.
Apart from the above, it is also important to mention that face masks should be used for source control, and not as personal protective equipment. Furthermore, barrier face coverings could also be used for source control. The said devices should comply with any and all applicable regulatory requirements in terms of filtration efficiency and airflow resistance. The FDA additionally emphasizes that neither face masks nor barrier face coverings are a substitute for NIOSH-approved respirators (including N95 respirators), which provide respiratory protection to the wearer, or for surgical masks, which provide fluid barrier protection and particular filtration to the wearer.
Initially, additional regulatory flexibility with respect to the abovementioned products has been introduced in April 2020 when the pandemic started. At that time, the industry faced a sudden increase in demand for such products, and it was vitally important to address the needs. In order to expand the availability of face masks, the authority has later issued an Emergency Use Authorisation, provided they meet specific criteria. Based on the abovementioned EUA, certain products could be placed on the market under a simplified procedure provided there is an unmet need due to the absence of alternatives among the products that are already registered and allowed for marketing and use.
In accordance with the policy described in the present guidance, the authority does not intend to object to the marketing and use of face masks and barrier face coverings intended to be used for marketing purposes without complying with certain regulatory requirements that could be temporarily waived, provided they are not exposing users and other persons to undue risks in the context of the pandemic. The said policy applies within the entire term of the public health emergency, and also 180 days thereafter. The policy is intended to provide additional flexibility to all the parties involved, including medical device manufacturers, healthcare providers, and patients.
The document further outlines the criteria to be applied when determining whether the policy described herein could be applied.
According to the guidance, face masks are not considered to create an undue risk where:
- They have proper labeling containing an accurate description, including the details on the patient-contacting materials,
- For non-NIOSH-approved FFRs to be used as face masks, the non-NIOSH-approved FFT is segregated from NIOSH-approved FFRs and clearly identified as a face mask for use as source control only;
- They do not contain any medicines, biologics, or nanoparticles;
- The labeling of the product refers to the environment in which the product should be used, including recommendations against use in any surgical setting or where significant exposure to liquid, bodily, or other hazardous fluids may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high; and use in the presence of a high-intensity heat source or flammable gas;
- The product is not supposed to expose users to additional risks when being used for the intended purpose.
Apart from the above, the document also outlines the criteria to be applied with respect to barrier face coverings. According to the guidance, these criteria include, inter alia, the following one: the product is labeled as a barrier face covering and is evaluated in accordance with 42 CFR Part 84 and consistent with ASTM F3502-21: Standard Specification for Barrier Face Coverings. The rest of the criteria are similar to the ones applied with respect to face masks.
In summary, the present FDA guidance describes in detail the special policy the authority applies in order to ensure and expand the availability of face masks and barrier face coverings during the public health emergency in order to meet the increasing needs. According to the said policy, these products could be placed on the market under a simplified procedure with certain requirements being waived.
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