On March 25, 2020, the Food and Drug Administration (FDA) issued a detail-rich guidance about its “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency” with the stated intent to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals (HCPs). The guidance applies to masks and respirators covered by 21 CFR 878.404 and 880.62.60. FDA stressed again that it does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available.
The guidance can be read as two separate parts: one that addresses FDA’s likely non-objections to distribution and use of face masks that are or are not intended to provide liquid barrier protection, and a second part that addresses potential Emergency Use Authorizations for respirators and masks. Readers interested in the details of each section should refer to the guidance; an incomplete summary of the contents is provided here.
Face Masks That Are or Are Not Intended to Provide Liquid Barrier Protection
For medical device face masks that are not intended to provide liquid barrier protection, FDA does not intend to object to distribution and use of such masks that do not meet the following regulatory requirements for approved devices, if risks can be managed through appropriate labeling:
- Prior submission for premarket notification under a 510(k)
- Registration and listing requirements
- QS regulation requirements
- Reports, corrections or removals
- Unique Device Identification requirements
For surgical masks that are intended to provide liquid barrier protection, FDA does not intend to object to distribution and use of such masks that do have a prior submission for premarket notification, if the product conforms to fluid resistance standards, meets flammability requirements, includes accurate labeling, and is not intended for any use that would create an undue risk.
Emergency Use Authorizations (EUAs) for Respirators and Masks
FDA has granted two relevant EUAs. On March 2, 2020, FDA granted an EUA that permits the emergency use and distribution to health care workers and to others, to mitigate further transmission of COVID-19, of filtering facepiece respirators (FFR) that are NIOSH-certified and that had previously been intended for general use. FDA has clarified that, given the new intended medical uses of those FFRs, those FFRs are medical devices.
On March 28, 20201, in response to FFR shortages, FDA granted an EUA for certain imported disposable FFRs that are not NIOSH-approved. Under this EUA, respirators that meet criteria satisfy the eligibility criteria and other terms and conditions can be authorized and listed on “Exhibit 1.” To be added to Exhibit 1, manufacturers and importers must send a request to FDA by email of their intent to import non-NIOSH approved disposable respirators that are eligible for authorization. With this second EUA, FDA also posted a Non-NIOSH Approved Respirator EUA FAQ on its website.
Under the new guidance, FDA is further employing the EUA process for potential reprocessing of filtering facepiece respirators. A reprocessed single-use device is an original device that has been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The guidance indicates that FDA is interested in interacting with manufacturers on the reprocessing of otherwise disposable N95 particulate filtering facepiece respirators (and other Filtering Facepiece Respirators), removing the typical requirement to submit a 510(k), to facilitate marketing authorization through an emergency use authorization (EUA) for reprocessed devices.
FDA recommends that interested firms contact FDA at CDRH-COVID19- SurgicalMasks@fda.hhs.gov and provide, in part, the following types of information to help facilitate the pre-EUA discussions:
- A description of the process for disinfection/reprocessing controls, including critical cycle parameters
- Validation of bioburden reduction/disinfection
- A description of chain of custody and safeguards to prevent inadvertent exposure
- Material compatibility, such as evidence to demonstrate that the materials used in both the filters and the straps (elastic bands) are compatible with the proposed reprocessing cycle steps
- Filtration performance, including evidence to demonstrate that repeated exposure to reprocessing cycles does not interfere with the filtration ability or breathability of the masks
- Effects of reprocessing on fit
- A copy of the reprocessed device product labeling, which FDA recommends should:
- Clearly state the mask is reprocessed
- Identify how many times the mask may be reprocessed
- Advise users to discard masks that are visibly damaged or that fit poorly and not reprocess
- Identify materials (including filter and strap/elastic band) that are incompatible with your proposed reprocessing cycle
For face masks intended for a medical purpose, surgical face masks, and N95 respirators that do not fall within the scope of the March 2 or March 28 EUAs, described above, FDA is interested in interacting with manufacturers on additional device-specific EUAs. This may include manufacturers of masks and respirators that are not currently legally marketed in the U.S. as well as manufacturers that have not previously manufactured masks or respirators with capabilities to increase supply of these devices.
Such foreign or domestic manufacturers should send the following information to FDA at CDRH-COVID19-SurgicalMasks@fda.hhs.gov as part of assessing whether the device would be able to meet the EUA requirements.
Current face mask and respirator manufacturers whose products are not currently marketed in the U.S. should provide requested information listed in the guidance, which includes contact information, name and place of business, a copy of the product labeling, whether the device currently has marketing authorization in another regulatory jurisdiction, whether the device is manufactured in compliance with 21 CFR Part 820 or ISO 13485 or an equivalent quality system, and a description of testing conducted on the device.
Face mask manufacturers that have not previously been engaged in medical device manufacturing but may have capabilities to increase the supply of these devices should send an email to the address above and describe their proposed approach. FDA intends to work collaboratively with these manufacturers through its EUA process.
1 The FDA first issued the EUA on March 24, 2020, but reissued the EUA in its entirety with minor amendments on March 28, 2020.
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