Document ID: FDA-2020-N-1584-0003
Agency: fda
Document Type: Notice
Title: Revocation of Authorization of Emergency Use of a Medical Device During COVID–19; Availability
Posted Date: 2021-04-01T04:00Z

[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Pages 17162-17164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06711]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1584]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

[[Page 17163]]

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.
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    Dated: March 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06711 Filed 3-31-21; 8:45 am]
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