Document ID: FDA-2021-N-0412-0001
Agency: fda
Document Type: Notice
Title: Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2021-05-28T04:00Z

[Federal Register Volume 86, Number 102 (Friday, May 28, 2021)]
[Notices]
[Pages 28841-28849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11385]

[[Page 28841]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0412]

Revocation of Authorization of Emergency Use of an In Vitro 
Diagnostic Device for Detection and/or Diagnosis of 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 BioFire Diagnostics, LLC for the BioFire Respiratory Panel 
2.1 (RP2.1). FDA revoked this Authorization on March 17, 2021, under 
the Federal Food, Drug, and Cosmetic Act (FD&C Act), in consideration 
of the De Novo classification order for the BioFire Respiratory Panel 
2.1 (RP2.1) as a Class II (Special Controls) device under the generic 
name ``Device to detect and identify nucleic acid targets in 
respiratory specimens from microbial agents that cause the SARS-CoV-2 
respiratory infection and other microbial agents when in a multi-target 
test.'' The revocation, which includes an explanation of the reasons 
for revocation, is reprinted in this document.

DATES: The Authorization is revoked as of March 17, 2021.

ADDRESSES: Submit written requests for single copies 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) as amended by the 
Project BioShield Act of 2004 (Pub L. 108-276) and the Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013 (Pub L. 113-5) 
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 May 1, 2020, FDA issued an 
EUA to BioFire Diagnostics, LLC for the BioFire Respiratory Panel 2.1 
(RP2.1), subject to the terms of the Authorization. Notice of the 
issuance of the Authorization was published in the Federal Register on 
July 14, 2020 (85 FR 42407), as required by section 564(h)(1) of the 
FD&C Act. In response to requests from BioFire Diagnostics, LLC, the 
EUA was amended on December 22, 2020.

II. EUA Criteria for Issuance No Longer Met

    Under section 564(g)(2) of the FD&C Act, the Secretary of Health 
and Human Services may revoke an EUA if, among other things, the 
criteria for issuance are no longer met. On March 17, 2021, FDA revoked 
the EUA for the BioFire Respiratory Panel 2.1 (RP2.1) because the 
criteria for issuance were no longer met. Under section 564(c)(3) of 
the FD&C Act, an EUA may be issued only if FDA concludes there is no 
adequate, approved, and available alternative to the product for 
diagnosing, preventing, or treating the disease or condition. FDA 
issued a De Novo classification order for the BioFire Respiratory Panel 
2.1 (RP2.1) as a Class II (Special Controls) device under the generic 
name ``Device to detect and identify nucleic acid targets in 
respiratory specimens from microbial agents that cause the SARS-CoV-2 
respiratory infection and other microbial agents when in a multi-target 
test'' on March 17, 2021, (https://www.accessdata.fda.gov/cdrh_docs/pdf20/DEN200031.pdf). FDA has concluded that this is an adequate, 
approved, and available alternative to BioFire Diagnostics, LLC's 
BioFire Respiratory Panel 2.1 (RP2.1) EUA product for detection and/or 
diagnosis of the virus that causes COVID-19.

III. Electronic Access

    An electronic version of this document and the full text of the 
revocation are available on the internet at https://www.regulations.gov/.

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 BioFire Respiratory Panel 2.1 (RP2.1). 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.
BILLING CODE 4164-01-P

[[Page 28842]]

[GRAPHIC] [TIFF OMITTED] TN28MY21.003

[[Page 28843]]

[GRAPHIC] [TIFF OMITTED] TN28MY21.004

[[Page 28844]]

[GRAPHIC] [TIFF OMITTED] TN28MY21.005

[[Page 28845]]

[GRAPHIC] [TIFF OMITTED] TN28MY21.006

[[Page 28846]]

[GRAPHIC] [TIFF OMITTED] TN28MY21.007

[[Page 28847]]

[GRAPHIC] [TIFF OMITTED] TN28MY21.008

[[Page 28848]]

[GRAPHIC] [TIFF OMITTED] TN28MY21.009

[[Page 28849]]

[GRAPHIC] [TIFF OMITTED] TN28MY21.010

    Dated: May 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11385 Filed 5-27-21; 8:45 am]
BILLING CODE 4164-01-C