2021-06711. Revocation of Authorization of Emergency Use of a Medical Device During COVID-19; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to NovaSterilis, Inc. for the Nova2200 using the NovaClean decontamination process. FDA revoked the Authorization on February 12, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.

DATES:

The Authorization for the Nova2200 using the NovaClean decontamination process is revoked as of February 12, 2021.

ADDRESSES:

Submit written requests for a single copy of the revocation to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the revocation may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT:

Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 240-402-8155 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. On August 20, 2020, FDA issued the Authorization. Notice of the issuance of the Authorization was published in the Federal Register on November 20, 2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act. FDA authorized the Nova2200 using the NovaClean decontamination process for use in decontaminating compatible N95 respirators identified in the EUA consistent with the Authorization. Subsequent to the issuance of the Authorization, as described in the revocation letter reprinted in this notice, FDA considered new data and evidence, including from testing performed by the Centers for Disease Control and Prevention (CDC) and in published literature, indicating that the compatible N95 respirators identified in the EUA may not maintain adequate fit and filtration efficiency following one decontamination cycle using the authorized product.

II. EUA Criteria for Issuance No Longer Met and Other Circumstances Make Revocation Appropriate To Protect the Public Health or Safety

Under section 564(g)(2)(B) and (C) of the FD&C Act, the Secretary of HHS may revoke an EUA if, among other things, the criteria for issuance are no longer met or other circumstances make such revocation appropriate to protect the public health or safety. On February 12, 2021, FDA revoked the Authorization because the criteria for issuance were no longer met and other circumstances made such revocation appropriate to protect the public health or safety. Under section 564(c)(2) of the FD&C Act, an EUA may be issued only if FDA concludes that, based on the totality of scientific evidence available, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing such disease or condition and that the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product.

Given the new data and evidence from CDC and recently reported in the literature, FDA has concluded it is not reasonable to believe the product may be effective in preventing healthcare provider exposure to pathogenic biological airborne particulates. Additionally, based on this new information, FDA can no longer conclude that the known and potential benefits of the product outweigh the known and potential risks of its emergency use. Further, based on the same information and the risks to public health and to healthcare providers from using decontaminated respirators with reduced fit and filtration performance, FDA has concluded under section 564(g)(2)(C) of the FD&C Act that other circumstances make revocation appropriate to protect the public health or safety. Accordingly, FDA has revoked the Authorization, pursuant to section 564(g)(2)(B) and (C) of the FD&C Act.

III. Electronic Access

An electronic version of this document and the full text of the revocations are available on the internet at https://www.regulations.gov/​ and https://www.fda.gov/​media/​145913/​download.

IV. The Revocation

Having concluded that the criteria for revocation of the Authorization under section 564(g) of the FD&C Act are met, FDA has revoked the EUA for the Nova2200 using the NovaClean decontamination process. The revocation in its entirety follows and provides an explanation of the reasons for revocation, as required by section 564(h)(1) of the FD&C Act.

Dated: March 24, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.