With shortages looming, the FDA allows unprecedented flexibility for marketing respirators and masks

New FDA policies to permit reprocessing respiratory equipment and allowing unapproved or uncleared devices on the market represent a changing dynamic under the agency’s traditionally risk-averse framework.


To contact the author of this analysis, please email Laura DiAngelo.
To contact the editor of this analysis, please email Alec Gaffney.


Executive IQ Brief

  • How Things Work Now: In general, products must be approved or cleared by the FDA before coming to market. This also applies to devices intended to be reprocessed or disinfected.
  • What’s New: With the outbreak of the novel coronavirus, the FDA issued guidance outlining policies to increase the supply of respirators and other facemasks. These include policies to allow the use of non-medical respirators in health care settings, the importation of non-FDA-approved (or cleared) respirators for use in the US, and policies to reprocess single-use respirators for additional usages by health care professionals.
  • Impact: It’s unclear if the policies will be sufficient to increase the number of respirators for front line health care professionals. However, the new policies expand beyond the regulatory flexibility granted to ventilators earlier this month, indicating that the FDA is working with a new risk-benefit framework for COVID-19. With the agency accepting unprecedented levels of risk in medical devices at significantly reduced oversight, the FDA’s ability to track or take action against adverse events is likely to be limited.
  • What’s Next: The policies are effective immediately, and will remain in effect for the duration of the public health emergency.

Regulatory Background

Although respiratory equipment can be used in a variety of settings, including construction and environmental work, respiratory equipment intended for use in health care settings are subject to regulatory oversight by the FDA as a medical device.

Respiratory devices such as respirators, N95 respirators, and similar facial protection devices including surgical masks are regulated by the FDA as a Class II (moderate risk) device. This means that devices of this type are ordinarily required to submit a pre-market notification, also known as a 510(k), to the agency before gaining market access. Clearance of a 510(k) is granted based on how “substantially equivalent,” or generally the same, a new device is to one that is already legally marketed (“predicate device”).

In certain circumstances the FDA shares regulatory authority with the CDC over N95 respirators intended for use in a health care setting. In addition to the 510(k) process, these types of respirators are also subject to certification from the CDC National Institute for Occupational Safety and Health (NIOSH).


Before 2018, manufacturers of N95 respirators were required to submit both 510(k)s and requests for approval to NIOSH. However, the agencies took action in the past two years to streamline the regulation of these products, reducing redundancies and reduce duplicative processes. Under the 21st Century Cures Act, the FDA was directed to exempt some devices from the premarket notification process, either on its own initiative or after a petition from a stakeholder. The policy was intended to help the FDA re-focus its available resources on higher-risk devices.


In 2018, the FDA exercised this authority by exempting N95s from the 510(k) process by issuing a final order in the Federal Register. Under an Memorandum of Understanding (MOU) between the FDA and CDC, a new policy was outlined: For N95s intended for use in health care settings, NIOSH will first review the device and determine if the device exceeds a baseline of evaluation criteria based on its understanding of the device. If the device meets the NIOSH approval criteria, it is permitted to be marketed and exempt from the 510(k) program. If the device exceeds the threshold of NIOSH’s established criteria, the agency will make a recommendation to the FDA, but the device will be subject to 510(k) oversight.


Even if a product is approved via the NIOSH process, the FDA is still responsible for post-market oversight, although it is supplemented by NIOSH postmarket surveillance authority.


This policy is only in place for N95 respirators intended for use in a health care setting, however. Other medical respiratory equipment, including products that fall under the same regulatory citation as N95s, are subject entirely to regulatory requirements from the FDA. Those products include surgical masks, pediatric and child face masks, surgical masks with an associated antimicrobial/antiviral agent and surgical (non-N95) respirators.


Additionally, N95 respirators intended for use in a public health emergency by non-medical professionals (i.e., by the general public), which have different regulatory citations, continue to fall under the authority of the FDA alone. Filtering facemasks and respirators that are used in industries other than health care remain under the purview of CDC alone.



Regulatory Context

With the continuing outbreak of COVID-19, health care workers have been raising significant concerns about a lack of Personal Protective Equipment (PPE) available for use. These products, including respirators, face shields and surgical gowns, are tools that allow providers to interact with and treat individuals who are highly contagious while mitigating the risk of infection to the clinician.


Reports from both state lawmakers and frontline health care workers indicate that there is not a sufficient supply of PPE, and especially N95 respirators, to last for the expected duration of the outbreak. In general, these products are intended to be used a single time and then disposed, and are not intended for re-use.


Congress recently took action to incent increased production of respirators, including respiratory equipment under the definition of covered countermeasures in its $2 trillion COVID-19 package, the CARES Act.


Earlier in the month, the FDA issued an Emergency Use Authorization (EUA), requested by the CDC, to allow health care providers to use N95 respirators that were NIOSH approved for non-health care settings, such as construction. While the Vice President has urged construction companies to donate their N95 respirator supply to health care workers, those actions do not appear to have been sufficient to alleviate supply shortages at medical facilities.



What’s New

Given both ongoing and expected shortages of respirators and other PPE, the FDA’s policies on respirator use and access have evolved dramatically in the past week.

The agency’s approach is two-pronged:


  • increasing the supply of filtering facepiece respirators (FFRs) on the market by expanding access to non-FDA cleared and non-NIOSH approved products, and
  • extending the shelf life of existing FFRs through decontamination methods.


New products on the market

On March 24, the FDA issued a new EUA for filtering facepiece respirators (FFR), including N95 respirators, allowing certain imported products that are not NIOSH-approved to be distributed to health care personnel. The policy was updated on March 28. Under this EUA, importers may bring certain products, or products approved or cleared by certain regulators, into the US to be used by providers in the US.

The EUA covers six specific product classifications performance standards from six regulatory bodies, as well as certain approval/clearance types from four regulatory bodies. These include:


  • Any disposable FFRs that have been approved or cleared with a European CE Mark, Australian Certificate of Inclusion, Health Canada License, or marketing authorization through Japan’s Pharmaceuticals and Medical Device Agency.
  • Six product standards for specific devices in Australia, Brazil, Europe, Japan, Korea and Mexico.

Even if the devices may be imported more easily, importers of the devices are still subject to filing and oversight requirements from the US Customs and Border Protection Agency. To help importers navigate the updated standards, the FDA and Customs and Border Protection issued supplemental guidanceclarifying to which agency information from importers should be submitted. For example, the importation of respiratory equipment or other general products not originally intended for health care use (e.g., gloves) will not require a ‘disclaim’ from the FDA. However, any product imported under the EUA does have to include the Compassionate Use or Emergency Use code on its importation request. Products imported under an enforcement discretion policy (e.g., ventilators) must also include the appropriate code for Customs, which is 081.006: Enforcement discretion per final guidance.


On March 25, the FDA issued another guidance on enforcement policies on respirators and other types of face masks. The products covered under the guidance include surgical and child face masks, surgical masks with antimicrobial/antiviral agents, surgical respirators, N95s with antimicrobial/antiviral agents, and N95s intended for use by the general public (both with and without antimicrobial/antiviral agents). Under that policy, the FDA asked importers with devices that do not fall under the categories in the March 24 EUA, such as products cleared or approved in another country, to submit individual EUAs.



Extending the use of FFRs

The March 25 guidance also included an EUA for reprocessed FFRs, including N95s. In regular circumstances, reprocessing single-use devices generally requires the submission of a 510(k) to the FDA. For the duration of the public health emergency, however, the FDA states that it is “interested in interacting with manufacturers on the reprocessing of otherwise disposable N95 particulate filtering facepiece respirators… to facilitate marketing authorization through an [EUA].”


The best practices for reprocessing an FFR in times of public health emergency are outlined under research sponsored by the FDA and the CDC, last updated on March 22. The report notes that, in the case of a public health emergency, “there will be an expected shortage of FFRs,” and researchers identified how and when providers should consider decontamination methods to help extend usage of the FFR that is available to them.


According to that report, ultraviolet (UV) decontamination methods are the optimal strategy for decontaminating otherwise single-use N95 FFRs, rather than microwave-generated steam or warm moist heat. UV germicidal irradiation (UVGI), compared to those methods, is both rapidly scaled and can be implemented in whole-room decontamination processes in a hospital.


For reusable respirators, such as Powered Air-Purifying Respirators (PAPRs) and Half-Mask Elastomeric Respirators (HMERs), research found that hospitals should use both manual reprocessing and automated reprocessing methods.


In general, the report indicates that single-use FFRs can be adequately decontaminated by UV Decontamination and Reuse (UVDR) in multiple cycles, although it’s unclear exactly how many times FFRs can be decontaminated until they no longer provide protection. Because the products are specifically designed for single-use, the physical design of the product (which is not intended to be taken off and put back on again after the original fitting) would “likely have more of an adverse impact on FFR performance” than decontamination. For products intended for reuse, the same problem applies: fabric straps or small cracks or pieces of the device can be harder to clean, requiring both manual and automated decontamination procedures.


Under the March 25 guidance on FFR policy, the FDA states that it “will work with reprocessors” to help navigate the EUA applications. In general, entities should include the following information in their EUA request for reprocessing FFRs:


  • A description of the process for disinfection and reprocessing controls (e.g., critical cycle parameters, chemical and biological indicators)
  • Validation of the bioburden reduction and disinfection
  • Description of the chain of custody and safeguards to prevent inadvertent exposure to soiled materials
  • Material compatibility (including how the non-filter components, such as the straps, hold up throughout reprocessing)
  • Filtration performance after reprocessing
  • Fit test data on the reprocessed product
  • Clear labelling for the device, including a statement that it has been reprocessed, advise on when to discard a visibly damaged FFR, and any materials of the FFR that would not be compatible with the proposed reprocessing cycle.

Aligning with this policy, the FDA released a separate policy on sterilizing, disinfecting, and purifying devices, including UV sterilizing products, on March 30. Under that policy, the FDA stated that it will exercise enforcement discretion over modifications to an already marketed disinfectant device that would have otherwise required either a new 510(k) or a new Premarket Approval (PMA) submission to the agency. In addition, the agency states that it will also allow the distribution of non-approved or cleared products that “are intended to be effective at killing the SARS-CoV-2 virus” but are not an already cleared or approved device. In both circumstances, the FDA will waiver premarket approval or clearance requirements, registration and listing requirements, and unique device identification (UDI) requirements.



Non-FFRs

The March 25 guidance further states that the FDA does not intend to take action against manufactures of face masks (not including respirators) that are intended for medical use only to be distributed to the general public. Additionally, the agency will exercise enforcement discretion (i.e., not take action against manufacturers for violating regular policy) over surgical masks that are intended to provide liquid barrier protection—allowing manufacturers to bring these products to market without submitting a request to the agency. Although these products must still meet fluid resistance testing and flammability standard requirements, the agency will not require premarket notification of these Class II devices for the duration of the emergency.



What’s Next

The FDA’s actions on respirator policy echo those on ventilator policy from earlier this month. As the FDA continues to update its thinking on how it will enforce certain policies, including expanding the allowable uses of devices and importing of non-FDA-approved products into the US, these policies represent a serious policy change for the agency. As AgencyIQ has noted previously, the FDA’s risk-benefit framework, which has been traditionally risk averse, appears to have shifted significantly in the face of the novel coronavirus epidemic.


The reprocessing and repurposing of single-use is not without risk. One recent, notable example of a reprocessing issue is the case of duodenoscopes, which were found to be difficult to clear and resulted in the transmission of diseases from patient to patient. The FDA has since recommended that hospitals move away from those devices in favor of single-use products or those with new design features intended to better facilitate cleaning.


One major concern is device counterfeiting. Although the FDA has been proactive about cracking down on entities selling products that incorrectly claim to treat or prevent COVID-19, medical devices that are not cleared or approved but distributed under this guidance may be more difficult to identify. Unlike pharmaceutical products, medical devices do not have a track-and-trace system which could allow counterfeit product to be more easily tracked.


In general, it does appear that the level of risk that the FDA is willing to accept is increasing over time as SARS-CoV-2 spreads. The recall of these non-approved products from the market following its conclusion—as well as the post-outbreak retrospective of the policies and their impact—is likely to focus on the flexibilities granted and potential lack of oversight into how they operated on the ground.



Key Documents and Dates

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