The Food and Drug Administration (FDA) issued guidance to provide recommendations for industry representatives applying for the Emergency Use Authorization (EUA) for decontamination and bioburden reduction systems. The document describes special extraordinary measures temporarily implemented by the Agency to address issues related to the outbreak of the COVID-19. Due to the pandemic and the public health emergency associated thereto, the present FDA guidance is subject to immediate implementation without prior public consultations as prescribed by the general rules. The document will be in force only within the term of a public health emergency. 

Regulatory Background 

The present FDA guidance is intended to provide applicants with additional recommendations regarding the information to be provided to the Agency when submitting an application for the EUA for decontamination and bioburden reduction systems. The Emergency Use Authorization is a special framework introduced by the FDA in order to ensure and expand the availability of vitally important medical devices during the pandemic. In particular, it allows for medical devices to be placed on the market and made available for healthcare professionals before being properly approved by the FDA in accordance with the general procedure. The recommendations provided in the FDA guidance are based on the intended purpose of a medical device in question, and the level of decontamination or bioburden reduction, the system provides. The system covered by the scope of the guidance could be used for N95 respirators and other personal protective equipment (PPE) actively used by healthcare professionals during the COVID-19 outbreak.

The scope of the FDA guidance covers the information to be included in pre-EUA or EUA requests, as well as special requirements related to the labeling of the aforementioned systems. The Agency acknowledges the significant increase in demand on face masks and personal protective equipment for healthcare professionals during the pandemic and intends to implement all reasonably necessary measures to assist manufacturers in meeting this demand and ensuring the availability of these devices on the US market. 

The Agency states that there are no already FDA-approved devices intended for the purpose described herein. In order to expand the availability of such devices, the Agency provides recommendations regarding the information to be provided by the applicants in order to confirm compliance with the applicable safety and performance requirements set forth in Section 564(c) of the Federal Food, Drug and Cosmetic Act. 

Recommendations for EUA Applicants 

Under the general rule, the device intended to be used for reprocessing single-use medical devices should be approved by the regulating authority on the basis of the 510(k) submission. In most of the cases, the Agency recommends using the medical devices approved by the FDA. At the same time, due to the lack of FDA-approved medical devices intended for the aforementioned purpose, the FDA is going to implement special rules and procedures to encourage medical device manufacturers from producing systems intended for decontaminating or reducing the bioburden of single-use medical devices and personal protective equipment. This is only provided that the medical device or PPE in question, meets the mandatory safety and effectiveness requirements set forth by the appropriate regulation. 

The Agency states that when reviewing the application for EUA, it will consider the following key points:

  • The intended purpose of the decontamination or bioburden reduction system
  • The level of evidence supporting such decontamination or bioburden reduction,
  • Evidence supporting user safety with respect to exposure to decontamination or bioburden reduction process residuals, and
  • Evidence supporting the continued effectiveness of compatible surgical masks and respirator following decontamination or bioburden reduction with regard to filtering, fir, and breathability, and product labeling.

The Agency states that the aforementioned information would be rigorously evaluated in the course of the Emergency Use Authorization application review.

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Regulatory Approach to EUA Applications 

The document also describes the approach that the FDA applies when reviewing the applications for the EUA for decontamination and bioburden reductions systems intended to be used for surgical masks and respirators in the context of the pandemic. 

In particular, the FDA guidance describes the conditions for authorization to be met. These conditions include, inter alia, the following ones:

  1. The potential users of the device subject to review should be duly informed about:
    1. The EUA granted by the Agency,
    2. The benefits and risks associated with the use of the device,
    3. Alternative devices that are already available on the market.
  2. The instructions for use supplied with the device should cover the following aspects:
    1. Indications of single-use medical devices and personal protective equipment compatible with the device in question.
    2. Restrictions and limitations for use (e.g. “to be used with the FDA-approved devices and PPE only”). 
    3. Operations with surgical masks and respirators, including collection, sorting, and discarding. 
    4. Indication of the number of cycles.
    5. Requirements and recommendations regarding safety measures to be taken by the user of the device. 
  3. Monitoring and reporting requirements and conditions providing that it is necessary to report about:
    1. Incidents with personnel using the medical devices and personal protective equipment that have already passed decontamination or bioburden reduction, and
    2. Incidents with the operators of the device itself.
  4. Record-keeping requirements. 

According to the guidance, all pre-EUA and EUA applications should be submitted in the electronic form via the appropriate email indicated by the Agency. 

The Hierarchy for Decontamination and Bioburden Reduction Systems

The FDA states that all critical cycle parameters should be well-controlled and predictable. The applicant shall also provide the Agency with evidence confirming compliance with the aforementioned requirements. The level of evidence should depend on the intended purpose of the device subject to review. In particular, the FDA utilizes a tier-based system that determines the requirements that the device in question should meet. 

The hierarchy provided by the FDA is actually based on several key parameters. The tier-based system described hereabove includes the following tiers:

  1. Tier 1: Decontamination of surgical masks and/or respirators for single- or multiple users. The devices falling within the scope of this category should demonstrate sufficient sporicidal or mycobactericidal decontamination. 
  2. Tier 2: Decontamination of surgical masks and/or respirators for singe-users only. The devices of this tier should demonstrate sufficient viral or vegetative bacterial decontamination. 
  3. Tier 3: Bioburden reduction of N95 respirators for single-users only to supplement existing CDC reuse recommendations.
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Content of the Pre-EUA Submissions

As it was already mentioned before, the document also describes the information to be included in the Pre-EUA submission. The Agency states that the following information should be provided:

  1. Information about the intended use of the system subject to review,
  2. A detailed description of the particular technology the system is based on,
  3. Details regarding the decontamination process,
  4. Validation,
  5. Compliance with the compatibility requirements,
  6. Evidence confirming the effectiveness of the system,
  7. Information regarding compatibility with particular medical devices and personal protective equipment.
  8. Information about the decontamination/bioburden reduction cycles.
  9. Information regarding preventive and protective measures.

Summarizing the information provided hereabove, the present FDA guidance describes the requirements that decontamination and bioburden reduction systems intended to be used for surgical masks and respirators should meet in order to be eligible for the Emergency Use Authorization.

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