Source: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/ah7n9-influenza-rapid-test-letter-authorization
Timestamp: 2020-01-23 06:52:52
Document Index: 102470427

Matched Legal Cases: ['§ 360', '§ 360', '§ 360', '§ 360', '§ 360', 'art 820', 'art 803']

A/H7N9 Influenza Rapid Test - Letter of Authorization
Peter Lu, M.D.
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Arbor Vita Corporation’s A/H7N9 Influenza Rapid Test for the presumptive detection of novel influenza A (H7N9) virus (detected in China in 2013) in patients with signs and symptoms of respiratory infection in conjunction with epidemiological risk factors, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3).
On April 19, 2013, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of Health and Human Services (HHS) determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such an agent or agents - in this case, novel influenza A (H7N9) virus.1 Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb-3(b)(1)), and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for the detection of influenza A (H7N9) virus, subject to the terms of any authorization issued under 21 U.S.C. § 360bbb-3(a).2
Having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(c)) are met, I am authorizing the emergency use of the A/H7N9 Influenza Rapid Test (as described in the scope section of this letter (Section II)) by Department of Defense (DoD) network laboratories in the U.S. and outside the U.S. or other U.S. government laboratories outside the U.S. in certain patients (as described in the scope section of this letter (Section II)) or by foreign laboratories for the presumptive detection of influenza A (H7N9) virus (detected in China in 2013), subject to the terms of this authorization.
I have concluded that the emergency use of the A/H7N9 Influenza Rapid Test for the presumptive detection of influenza A (H7N9) virus (detected in China in 2013) in the specified population meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded that:
The influenza A (H7N9) virus (detected in China in 2013) can cause influenza, a serious or life-threatening disease or condition to humans infected with this virus;
Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the A/H7N9 Influenza Rapid Test may be effective in diagnosing influenza A (H7N9) virus (detected in China in 2013) in the specified population, and that the known and potential benefits of the A/H7N9 Influenza Rapid Test, when used for diagnosing influenza A (H7N9) virus (detected in China in 2013) infection in the specified population, outweigh the known and potential risks of such product; and
There is no adequate, approved, and available alternative to the emergency use of the A/H7N9 Influenza Rapid Test for diagnosing influenza A (H7N9) virus (detected in China in 2013) in the specified population.3
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the use of the authorized A/H7N9 Influenza Rapid Test for the presumptive detection of influenza A (H7N9) virus (detected in China in 2013) in patients with signs and symptoms of respiratory infection in conjunction with epidemiological risk factors. This test is intended for use by DoD network laboratories in the U.S. and outside the U.S. or other U.S. government laboratories outside the U.S. for testing U.S. citizens living and traveling abroad in China and other affected areas and for U.S. military, Department of State, and other U.S. governmental agency personnel stationed and working in China and other affected areas who may potentially be exposed to influenza A (H7N9) virus (detected in China in 2013) or be exposed to individuals who may carry the influenza A (H7N9) virus (detected in China in 2013), or by foreign laboratories.
The Authorized A/H7N9 Influenza Rapid Test:
The A/H7N9 Influenza Rapid Test is an immunoassay in a lateral flow device configuration for the in vitro qualitative detection of A (H7N9) influenza virus (detected in China in 2013) in nasal swab specimens from patients presenting influenza-like illness (ILI) of respiratory infection in conjunction with epidemiological risk factors. The test detects the nonstructural protein 1 (NS1) of influenza A (H7N9) virus (detected in China in 2013). The test may react with NS1 protein antigen of other Asian avian influenza viruses, such as A/H9N2, A/H5N1, and A/H10N8.
The A/H7N9 Influenza Rapid Test has three components: Test Cassette, External Positive Control, and Lysis Buffer. The Test Cassette is a lateral flow device in which the input sample is lysed and applied to the Test Cassette to produce a red line that is read visually.
The A/H7N9 Influenza Rapid Test includes the following assay controls:
Internal control line (C) that functions as a run control to ensure proper functioning of the buffer reagents, capillary flow, and functional integrity of the test strip within the cassette.
A second control, Line 1 contains monoclonal antibodies that detect NS1 protein from all influenza A strains (Pan-influenza A).
Positive Control: recombinant influenza A (H7N9) NS1 protein in dried form (non-pathogenic)
Negative Controls: Lysis Buffer
The above described A/H7N9 Influenza Rapid Test, when labeled consistently with the labeling authorized by FDA, entitled “A/H7N9 Influenza Rapid Test Instructions for Use” (PDF - 337kb), which may be revised with written permission of FDA, is authorized to be distributed to and used by the DoD network laboratories in the U.S. and outside the U.S. or other U.S. government laboratories outside the U.S. under this EUA for testing U.S. citizens living and traveling abroad in China and other affected areas and U.S. military, Department of State, and other U.S. governmental agency personnel stationed and working in China and other affected areas who may potentially be exposed to influenza A (H7N9) virus (detected in China in 2013) or be exposed to individuals who may carry the influenza A (H7N9) virus (detected in China in 2013), or distributed to and used by foreign laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by federal law.
The above described A/H7N9 Influenza Rapid Test is authorized to be accompanied by the following information pertaining to the emergency use, which is authorized to be made available to health care professionals and patients:
Fact Sheet for Health Care Providers: Interpreting A/H7N9 Influenza Rapid Test Results
Fact Sheet for Patients: Understanding Results from the A/H7N9 Influenza Rapid Test
As described in section IV below, Arbor Vita Corporation is also authorized to make available additional information relating to the emergency use of the authorized A/H7N9 Influenza Rapid Test that is consistent with, and does not exceed, the terms of this letter of authorization.
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of the authorized A/H7N9 Influenza Rapid Test in the specified population, when used for presumptive detection of influenza A (H7N9) virus (detected in China in 2013), outweigh the known and potential risks of such a product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized A/H7N9 Influenza Rapid Test may be effective in the diagnosis of influenza A (H7N9) virus (detected in China in 2013) infection pursuant to section 564(c)(2)(A) of the Act. The FDA has reviewed the scientific information available, including the information supporting the conclusions described in Section I above, and concludes that the authorized A/H7N9 Influenza Rapid Test, when used to diagnose influenza A (H7N9) virus (detected in China in 2013) infection in the specified population, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the authorized A/H7N9 Influenza Rapid Test under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below. Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under section 564(b)(1)(C) described above and the Secretary of HHS's corresponding declaration under section 564(b)(1), the A/H7N9 Influenza Rapid Test described above is authorized to diagnose influenza A (H7N9) virus (detected in China in 2013) infection in the specified population in conjunction with epidemiological risk factors.
I am waiving the following requirements for the A/H7N9 Influenza Rapid Test during the duration of this emergency use authorization:
Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the A/H7N9 Influenza Rapid Test.
Labeling requirements for cleared, approved, or investigational devices, including labeling requirements under 21 CFR 809.10 and 809.30, except for the intended use statement (21 CFR 809.10(a)(2), (b)(2)), adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5), (7), and (8)), any appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4), and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).
Arbor Vita Corporation will distribute the authorized A/H7N9 Influenza Rapid Test with the authorized labeling, as may be revised with written permission of FDA, only to DoD network laboratories in the U.S. and outside the U.S., other U.S. government laboratories outside the U.S., or foreign laboratories.
Arbor Vita Corporation will provide to the appropriate DoD network laboratories in the U.S. and outside the U.S. and other U.S. government laboratories outside the U.S. the authorized A/H7N9 Influenza Rapid Test Fact Sheet for Health Care Providers and the authorized A/H7N9 Influenza Rapid Test Fact Sheet for Patients.
Arbor Vita Corporation will make available on its website the authorized A/H7N9 Influenza Rapid Test Fact Sheet for Health Care Providers and the authorized A/H7N9 Influenza Rapid Test Fact Sheet for Patients.
Arbor Vita Corporation will inform state and/or local public health authority(ies) of this EUA, including the terms and conditions herein.
All advertising and promotional descriptive printed matter relating to the use of the A/H7N9 Influenza Rapid Test shall clearly and conspicuously state that:
This test has been authorized for use only by DoD network laboratories in the U.S. and outside the U.S., other U.S. government laboratories outside the U.S., or foreign laboratories;
This test has been authorized only for the detection of influenza A (H7N9) virus (detected in China in 2013) and not for any other viruses or pathogens; and
This test is only authorized for the duration of the HHS declaration of emergency that justifies this authorization, unless the authorization is revoked sooner.
No advertising or promotional descriptive printed matter relating to the use of the authorized A/H7N9 Influenza Rapid Test may represent or suggest that this test is safe or effective for the diagnosis of influenza A (H7N9) virus (detected in China in 2013).
Arbor Vita Corporation will ensure that appropriate DoD network laboratories in the U.S. and outside the U.S. or other U.S. government laboratories outside the U.S. using the authorized A/H7N9 Influenza Rapid Test have a process in place for reporting test results to health care professionals and U.S. federal, state, and/or local public health authorities, as appropriate.
Arbor Vita Corporation will track adverse events and report to FDA as required under 21 CFR Part 803.
Through a process of inventory control, Arbor Vita Corporation will maintain records of device usage.
Arbor Vita Corporation will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive or false negative results of which Arbor Vita Corporation becomes aware.
Arbor Vita Corporation is authorized to make available additional information relating to the emergency use of the authorized A/H7N9 Influenza Rapid Test that is consistent with, and does not exceed, the terms of this letter of authorization.
Only Arbor Vita Corporation may request changes to the authorized A/H7N9 Influenza Rapid Test Fact Sheet for Health Care Providers or the authorized A/H7N9 Influenza Rapid Test Fact Sheet for Patients. Such requests will be made by contacting FDA concerning FDA review and approval.
DoD Network Laboratories in the U.S. and outside the U.S. and Other U.S. Government Laboratories outside the U.S.
DoD network laboratories in the U.S. and outside the U.S. and other U.S. government laboratories outside the U.S. will include with reports of the results of the A/H7N9 Influenza Rapid Test the authorized Fact Sheet for Health Care Providers and the authorized Fact Sheet for Patients.
DoD network laboratories in the U.S. and outside the U.S. and other U.S. government laboratories outside the U.S. will have a process in place for reporting test results to health care professionals and federal, state, and/or local public health authorities, as appropriate.
DoD network laboratories in the U.S. and outside the U.S. and other U.S. government laboratories outside the U.S. will collect information on the performance of the assay, and report to Arbor Vita Corporation any suspected occurrence of false positive or false negative results of which they become aware.
DoD network laboratories in the U.S. and outside the U.S. and other U.S. government laboratories outside the U.S. will clearly and conspicuously state on reports of the results of the A/H7N9 Influenza Rapid Test that this test is only authorized for the diagnosis of influenza A (H7N9) virus (detected in China in 2013) and not for seasonal influenza A, B, or any other pathogen.
Arbor Vita Corporation, DoD Network Laboratories in the U.S. and outside the U.S., and Other U.S. Government Laboratories outside the U.S.
Arbor Vita Corporation, DoD network laboratories in the U.S. and outside the U.S., and other U.S. government laboratories outside the U.S. will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
The emergency use of the authorized A/H7N9 Influenza Rapid Test as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
1 As amended by the Pandemic and All-Hazards Preparedness Reauthorization Act, Pub. L. No. 113-5, under section 564(b)(1)(C) of the Act the Secretary may make a determination of a public health emergency, or of a significant potential for a public health emergency.
2 U.S. Department of Health and Human Services. Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus. 78 Fed. Reg. 25273 (April 30, 2013).