2023-22188. Revocation of Eleven Authorizations of Emergency Use of 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 Authorizations (EUAs) (the Authorizations) issued to Luminostics, Inc., for the Clip COVID Rapid Antigen Test; NeuMoDx Molecular, Inc., a QIAGEN Company, for the NeuMoDx Flu A–B/RSV/SARS–CoV–2 Vantage Assay; LGC, Biosearch Technologies for the SARS–CoV–2 Real-Time and End-Point RT–PCR Test; LGC, Biosearch Technologies, for the Biosearch Technologies SARS–CoV–2 ultra-high-throughput End-Point RT–PCR Test; Becton, Dickinson and Co. for the BD Veritor At-Home COVID–19 Test; Verily Life Sciences for the Verily COVID–19 RT–PCR Test; Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP SARS–CoV–2 Real-time Reverse Transcriptase (RT)–PCR Diagnostic Assay (Version 3); Xtrava Health for the SPERA COVID–19 Ag Test; Exact Sciences Laboratories for the COVID–Flu Multiplex Assay; Exact Sciences Laboratories for the SARS–CoV–2 (N gene detection) Test; and dba SpectronRx for the Hymon SARS–CoV–2 Test Kit. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holders. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

DATES:

The Authorization for the Luminostics, Inc.'s, Clip COVID Rapid Antigen Test is revoked as of May 5, 2023. The Authorization for the NeuMoDx Molecular, Inc., a QIAGEN Company, for the NeuMoDx Flu A–B/RSV/SARS–CoV–2 Vantage Assay is revoked as of May 24, 2023. The Authorization for the LGC, Biosearch Technologies for the SARS–CoV–2 Real- Time and End-Point RT–PCR Test is revoked as of June 1, 2023. The Authorization for the LGC, Biosearch Technologies, for the Biosearch Technologies SARS–CoV–2 ultra-high-throughput End-Point RT–PCR Test is revoked as of June 1, 2023. The Authorization for the Becton, Dickinson and Co.'s BD Veritor At-Home COVID–19 Test is revoked as of June 15, 2023. The Authorization for the Verily Life Sciences' Verily COVID–19 RT–PCR Test is revoked as of June 21, 2023. The Authorization for the Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP SARS–CoV–2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) is revoked as of July 3, 2023. The Authorization for the Xtrava Health's SPERA COVID–19 Ag Test is revoked as of August 3, 2023. The Authorization for the Exact Sciences Laboratories' COVID–Flu Multiplex Assay is revoked as of August 18, 2023. The Authorization for the Exact Sciences Laboratories' SARS–CoV–2 (N gene detection) Test is revoked as of August 18, 2023. The Authorization for the dba SpectronRx's Hymon SARS–CoV–2 Test Kit is revoked as of August 23, 2023.

ADDRESSES:

Submit a written request for a single copy of the revocations to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 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 revocations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocations.

FOR FURTHER INFORMATION CONTACT:

Kim Sapsford-Medintz, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3216, Silver Spring, MD 20993–0002, 301–796–0311 (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, radiological, or nuclear agent or 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 December 7, 2020, FDA issued the Authorization to Luminostics, Inc., for the for the Clip COVID Rapid Antigen Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the FD&C Act. On March 25, 2021, FDA issued the Authorization to NeuMoDx Molecular, Inc., a QIAGEN Company, for the NeuMoDx Flu A–B/RSV/SARS–CoV–2 Vantage Assay, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on July 23, 2021 (86 FR 39040), as required by section 564(h)(1) of the FD&C Act. On April 15, 2021, FDA issued the Authorization to LGC, Biosearch Technologies for the SARS–CoV–2 Real-Time and End-Point RT–PCR Test. Notice of the issuance of this Authorization was published in the Federal Register on July 23, 2021 (86 FR 39040), subject to the terms of the Authorization. On August 24, 2021, FDA issued the Authorization to Becton, Dickinson and Co. for the BD Veritor At-Home COVID–19 Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on October 28, 2021 (86 FR 59740), as required by section 564(h)(1) of the FD&C Act. On April 26, 2022, FDA issued the Authorization to LGC, Biosearch Technologies, for the Biosearch Technologies SARS–CoV–2 ultra-high-throughput End-Point RT–PCR Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on July 22, 2022 (87 FR 43877), as required by section 564(h)(1) of the FD&C Act. On September 8, 2020, FDA issued the Authorization to Verily Life Sciences for the Verily COVID–19 RT–PCR Test, subject to the terms of the Authorization. Notice of the issuance of this 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. On March 5, 2021, FDA issued the Authorization to Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP SARS–CoV–2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3), subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on July 23, 2021 (86 FR 39040), as required by section 564(h)(1) of the FD&C Act. On October 12, 2021, FDA issued the Authorization to Xtrava Health for the SPERA COVID–19 Ag Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on March 22, 2022 (87 FR 16198), as required by section 564(h)(1) of the FD&C Act. On July 1, 2021, FDA issued the Authorization to Exact Sciences Laboratories for the COVID–Flu Multiplex Assay, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on October 28, 2021 (86 FR 59740), as required by section 564(h)(1) of the FD&C Act. On March 31, 2020, FDA issued the Authorization to Exact Sciences Laboratories for the SARS–CoV–2 (N gene detection) Test, subject to the terms of the Authorization. Notice of the issuance of this 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. On May 22, 2020, FDA issued the Authorization to dba SpectronRx for the Hymon SARS–CoV–2 Test Kit, subject to the terms of the Authorization. Notice of the issuance of this 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.

Subsequent updates to the Authorizations were made available on FDA's website. The authorization of a device for emergency use under section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked when the criteria under section 564(c) of the FD&C Act for issuance of such authorization are no longer met (section 564(g)(2)(B) of the FD&C Act), or other circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the FD&C Act).

II. Authorization Revocation Requests

In a request received by FDA on May 2, 2023, Luminostics, Inc. requested the withdrawal of, and on May 5, 2023, FDA revoked, the Authorization for the Luminostics, Inc.'s Clip COVID Rapid Antigen Test. Because Luminostics, Inc. notified FDA that there are no viable Clip COVID Rapid Antigen Test reagents remaining in distribution in the United States and requested FDA withdraw the Luminostics, Inc.'s Clip COVID Rapid Antigen Test, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

In a request received by FDA on May 11, 2023, NeuMoDx Molecular, Inc., a QIAGEN Company requested revocation of, and on May 24, 2023, FDA revoked, the Authorization for the NeuMoDx Molecular, Inc., a QIAGEN Company's, NeuMoDx Flu A–B/RSV/SARS–CoV–2 Vantage Assay. Because NeuMoDx Molecular, Inc., a QIAGEN Company, notified FDA that it has decided to discontinue distribution of the NeuMoDx Flu A–B/RSV/SARS–CoV–2 Vantage Assay in the United States and requested FDA voluntary revocation of the EUA for the NeuMoDx Flu A–B/RSV/SARS–CoV–2 Vantage Assay, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

In a request received by FDA on May 1, 2023, LGC, Biosearch Technologies requested revocation of, and on June 1, 2023, FDA revoked, the Authorization for the LGC Biosearch Technologies' SARS–CoV–2 Real-Time and End-Point RT–PCR Test. Because LGC, Biosearch Technologies notified FDA that it is no longer marketing the SARS–CoV–2 Real-Time and End-Point RT–PCR Test and requested FDA revoke the EUA for the LGC Biosearch Technologies SARS–CoV–2 Real-Time and End-Point RT–PCR Test, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

In a request received by FDA on May 1, 2023, LGC, Biosearch Technologies requested revocation of, and on June 1, 2023, FDA revoked, the Authorization for the LGC Biosearch Technologies' SARS–CoV–2 ultra-high-throughput End-Point RT–PCR Test. Because LGC, Biosearch Technologies notified FDA that it is no longer marketing the SARS–CoV–2 ultra-high-throughput End-Point RT–PCR Test and requested FDA revoke the EUA for the LGC Biosearch Technologies SARS–CoV–2 ultra-high-throughput End-Point RT–PCR Test, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

In a request received by FDA on May 30, 2023, Becton, Dickinson and Co. requested withdrawal of, and on June 15, 2023, FDA revoked, the Authorization for the Becton, Dickinson and Co.'s BD Veritor At-Home COVID–19 Test. Because Becton, Dickinson and Co. notified FDA that it has discontinued the sale of BD Veritor At-Home COVID–19 Test and requested FDA withdraw the EUA for the Becton, Dickinson and Co.'s BD Veritor At-Home COVID–19 Test, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

In a request received by FDA on June 13, 2023, Verily Life Sciences requested withdrawal of, and on June 21, 2023, FDA revoked, the Authorization for the Verily Life Sciences' Verily COVID–19 RT–PCR Test. Because Verily Life Sciences notified FDA that it is no longer distributing the Verily COVID–19 Nasal Swab Kits (authorized as part of the Verily COVID–19 RT–PCR Test) or offering testing services at the Verily Life Sciences' laboratory using the Verily COVID–19 RT–PCR Test and requested FDA withdraw the EUA for the Verily Life Sciences' Verily COVID–19 RT–PCR Test, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

In a request received by FDA on June 14, 2023, Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard, requested voluntary revocation of, and on July 3, 2023, FDA revoked, the Authorization for the CRSP, LLC at the Broad Institute of MIT and Harvard's CRSP SARS–CoV–2 Real-time Reverse Transcriptase (RT)–PCR Diagnostic Assay (Version 3). Because CRSP, LLC at the Broad Institute of MIT and Harvard notified FDA that it is no longer distributing the CRSP Self-swab Kits (authorized as part of the CRSP SARS–CoV–2 Real-time RT–PCR Diagnostic Assay (Version 3)) or offering testing services at the CRSP, LLC at the Broad Institute of MIT and Harvard laboratory using the CRSP SARS–CoV–2 Real-time RT–PCR Diagnostic Assay (Version 3), and requested FDA revoke the EUA for the CRSP, LLC at the Broad Institute of MIT and Harvard's CRSP SARS–CoV–2 Real-time RT–PCR Diagnostic Assay (Version 3), FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

In a request received by FDA on July 18, 2023, Xtrava Health requested the withdrawal of, and on August 3, 2023, FDA revoked, the Authorization for the Xtrava Health's SPERA COVID–19 Ag Test. Because Xtrava Health notified FDA that there are no SPERA COVID–19 Ag Test reagents in distribution in the United States and requested FDA withdraw the Xtrava Health's, SPERA COVID–19 Ag Test, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

In a request received by FDA on August 1, 2023, Exact Sciences Laboratories requested the withdrawal of, and on August 18, 2023, FDA revoked, the Authorization for the Exact Sciences Laboratories' COVID-Flu Multiplex Assay. Because Exact Sciences Laboratories notified FDA that they have discontinued use of the COVID-Flu Multiplex Assay at Exact Sciences Laboratories and requested FDA withdraw the Exact Sciences Laboratories' COVID-Flu Multiplex Assay, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

In a request received by FDA on August 1, 2023, Exact Sciences Laboratories requested the withdrawal of, and on August 18, 2023, FDA revoked, the Authorization for the Exact Sciences Laboratories' SARS–CoV–2 (N gene detection) Test. Because Exact Sciences Laboratories notified FDA that they have discontinued use of the SARS–CoV–2 (N gene detection) Test at Exact Sciences Laboratories and requested FDA withdraw the Exact Sciences Laboratories' SARS–CoV–2 (N gene detection) Test, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

In a request received by FDA on March 24, 2023, dba SpectronRx requested the withdrawal of, and on August 23, 2023, FDA revoked, the Authorization for the dba SpectronRx's Hymon SARS–CoV–2 Test Kit. Because dba SpectronRx notified FDA that they are discontinuing the distribution of the Hymon SARS–CoV–2 Test Kit and requested FDA withdraw the dba SpectronRx for the Hymon SARS–CoV–2 Test Kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.

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/​.

IV. The Revocations

Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUA of Luminostics, Inc.'s, Clip COVID Rapid Antigen Test, NeuMoDx Molecular, Inc., a QIAGEN Company's, NeuMoDx Flu A–B/RSV/SARS–CoV–2 Vantage Assay, LGC Biosearch Technologies' SARS–CoV–2 Real-Time and End-Point RT–PCR Test, LGC Biosearch Technologies' SARS–CoV–2 ultra-high-throughput End-Point RT–PCR Test, Becton, Dickinson and Co.'s BD Veritor At-Home COVID–19 Test, Verily Life Sciences' Verily COVID–19 RT–PCR Test, Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard's CRSP SARS–CoV–2 Real-time Reverse Transcriptase (RT)–PCR Diagnostic Assay (Version 3), Xtrava Health's SPERA COVID–19 Ag Test, Exact Sciences Laboratories' COVID-Flu Multiplex Assay, Exact Sciences Laboratories' SARS–CoV–2 (N gene detection) Test, and dba SpectronRx's Hymon SARS–CoV–2 Test Kit. These revocations in their entirety follow and provide an explanation of the reasons for each revocation, as required by section 564(h)(1) of the FD&C Act.

Dated: October 2, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.