FDA Revokes Emergency Use Authorizations for Non-NIOSH-Approved Disposable Respirators and Decontamination Systems as Access to FDA-authorized and NIOSH-approved N95s Increases Nationwide
On June 30, 2021, the FDA announced the revocation of the following EUAs:
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (effective July 6, 2021)
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (effective July 6, 2021)
- Decontamination and Bioburden Reduction System EUAs for Personal Protective Equipment (effective June 30, 2021)
As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings. For additional information, please see Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities.
Historical information regarding these EUAs can be found on Historical Information about Device Emergency Use Authorizations.
Q: Can health care personnel use Non-NIOSH-Approved Respirators for respiratory protection?
A: As of July 6, 2021, the FDA no longer authorizes for emergency use Non-NIOSH-approved respirators for health care personnel. For information on EUAs that were previously issued, including revoked EUAs, see Historical Information about Device Emergency Use Authorizations.
For respiratory protection, health care personnel should use only FDA-cleared or NIOSH-approved respirators, including N95s and other respirators under the Emergency Use Authorization (EUA) for NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency.
Q: What should health care providers and facilities do with non-NIOSH-approved respirators that may still be in inventory?
The FDA recommends that health care providers and facilities consider redistributing non-NIOSH-approved respirators that may still be in inventory, such as, to:
- Non-healthcare settings for non-medical use (for example, construction)
- Other countries in need (in accordance with the Federal Food, Drug, and Cosmetic Act export provisions) While it is possible that non-NIOSH-approved respirators may be reconditioned as face masks for use as source control (see, for example, Import Alert 89-18), the FDA does not recommend that non-NIOSH-approved respirators undergo reconditioning at this time because there is currently sufficient supply of source control medical devices, among other things.
For more information, see June 30, 2021 letter.
Q: Can I import and distribute a non-NIOSH-approved respirator manufactured outside of the United States that is not authorized under an EUA or FDA-cleared?
A: No. Respirators labeled as "respirators" and intended for a medical purpose must be cleared or authorized by the FDA in order to be imported or distributed.
Posted June 30, 2021, the FDA has revoked the EUAs for non-NIOSH-approved respirators effective July 6, 2021, and as of that date they are no longer authorized and can no longer be imported for health care personnel use. For FDA-cleared and NIOSH-approved respirators that may be imported, see FDA's 510(k) database or the NIOSH certified equipment list.
Import information can be found on the Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 page. If you need to resolve entry issues for shipments, please contact 301-796-0356 or [email protected].
Q: What options may I consider if my non-NIOSH-approved disposable filtering facepiece respirator model manufactured outside the United States is not authorized?
A. You may want to consider the following:
- As explained in the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), FDA device marketing authorization or clearance is not required for products that do not meet the definition of a device (for example, the product is labeled and marketed to the general public for general, non-medical purposes, such as use in construction).
- While it is possible that non-NIOSH-approved respirators may be reconditioned for use as source control (see for example as face masks in Import Alert 89-18), the FDA does not recommend that non-NIOSH-approved respirators undergo reconditioning at this time because there is currently sufficient supply of source control medical devices, among other things.