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.