FDA Approves Authorized Use of a COVID-19 Test Product

FDA did approve a COVID-19 test kit in November 2020 for Lucira COVID-19 All-In-One Test Kit manufactured by Lucira Health, Inc. The approval was based on an Emergency Use Authorization which was granted pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

The letter of authorization dated November 17, 2020, summarized the following issues:

• The intended use of the product
• The criteria for issuing the authorization
• The scope of the authorization
• A waiver of certain requirements – specifically, a waiver of “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 your product,” with certain exceptions
• The duration of the authorization

In addition, the authorization letter imposes numerous conditions on the authorization which the manufacturer must comply with. We list these conditions to show that EUA does require a lot of work once FDA approval is granted.

The conditions of the EUA the manufacturer must meet

Labeling requirements. The COVID-19 test product must meet the following labeling requirements:

1. “Your product must comply with the following labeling requirements:
   1. The intended use statement in 21 CFR 809.10(a)(2), (b)(2)
   2. Adequate directions for use in 21 U.S.C. 352(f) and 21 CFR 809.10(b)(5), (7), and (8)
   3. Appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4)
   4. Any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).”
2. The manufacturer and authorized distributors are required to make all the authorized labeling requirements set forth in the Scope of Authorization section – available on the company websites.
3. The manufacturer and authorized distributors must keep records of complaints by customers and report any significant complaints to FDA – about “usability or deviations from the established performance characteristics of which you and authorized distributor(s) become aware.”
4. The manufacturer and authorized distributors must keep public health authorities informed of this EUA – including the conditions and terms of the EUA – and including update product or labeling updates
5. The manufacturer and authorized distributors using an inventory control process must keep records of the places (such as pharmacies and doctor’s offices) where the testing kits are distributed and the number of test kits sent to each location.
6. The manufacturer and authorized distributors must have procedures in place to collect information about how the product is performing and to track any adverse events (such as false positives or false negatives and “significant deviations from the established performance characteristics of the product of which you become aware”. The adverse events must be sent to FDA in accordance with 21 CFR Part 803. “Serious adverse events, especially unexpected biosafety concerns, should immediately be reported to DMD/OHT7-OIR/OPEQ/CDRH (via email: [email protected]).”
7. The manufacturer and authorized distributors are also “authorized to make available additional information relating to the emergency use of your product that is consistent with, and does not exceed, the terms of this letter of authorization.”
8. The manufacturer must inform FDA of any authorized distributor(s) of your product, including the name, address, and phone number of any authorized distributor(s).
9. The manufacturer must give the authorized distributor a copy of this EUA. The manufacturer should inform each authorized distributor about any subsequent changes to the EUA and “its authorized accompanying materials, including the authorized labeling.”
10. The manufacturer must “include a physical copy of the Lucira Health COVID-19 All-In-One Test Kit Quick Reference Instructions with each shipped kit of your product, and must make the authorized Instructions for Use electronically available for healthcare providers.” The manufacturer must also give the healthcare provider the opportunity to ask for a copy of the Use Instructions in paper form – at no additional cost.
11. The manufacturer can request changes to this EUA for the product, “including to the Scope of Authorization or to the authorized labeling, including requests to make available additional authorized labeling specific to an authorized distributor.” “Such additional labeling may use another name for the product but otherwise must be consistent with the authorized labeling, and shall not exceed the terms of authorization of this letter.” Requests for changes to the EUQ should be made to the Division of Microbiology (DMD)/Office of Health Technology 7 (OHT7)-Office of In Vitro Diagnostics and Radiological Health (OIR)/Office of Product Evaluation and Quality (OPEQ)/Center for Devices and Radiological Health (CDRH) and require appropriate authorization from FDA prior to implementation.
12. The manufacturer must comply with several listed FDA regulations relating to acceptance activities, nonconforming products, and statistical techniques.
13. The manufacturer must have “lot release procedures and the lot release procedures, including the study design and statistical power, must ensure that the product released for distribution meet the clinical and analytical performance claimed in the authorized labeling.”
14. If FDA requests, the manufacturer must submit their lot release procedures to FDA. This includes providing protocols, testing protocols, and acceptance criteria – used to release lots of the testing product for US distribution, If FDA requests such release procedures, then the manufacturer must provide FDA within 48 hours of the date the FDA makes the request.
15. The manufacturer must “evaluate the analytical limit of detection and assess traceability of your product with any FDA-recommended reference material(s).” “After submission to and concurrence with the data by FDA, you will update your labeling to reflect the additional testing.” The labeling updates should be made in consultation with (and require concurrence) of DMD/OHT7-OIR/OPEQ/CDRH.
16. The manufacturer is required to develop a mobile phone application or a website which will help facilitate the reporting of results by health care providers and by the people using your product. The app or websites should be submitted to FDA within four months of the date of the letter – “unless otherwise agreed to with DMD/OHT7-OIR/OPEQ/CDRH).” Once the mobile phone app or website is submitted, “along with review of and concurrence with the developed mobile phone application or website by FDA, you must update the authorized labeling.” The labeling updates will be made in consultation with, and require concurrence of, FDA.
17. The manufacturer must provide FDA, within 60 days of authorization, a summary report summarizing any testing results performed using the product during those 60 days – including “how many products were distributed, the positivity rate for specimens tested with your product, and how many individuals reported results to their healthcare provider as encouraged by the Quick Reference Instructions.”

EUA conditions – healthcare providers

The EUA also imposes some conditions on the healthcare providers that use the manufacturer’s testing products.

1. The prescribing healthcare providers must collect data on the product’s performance “in the ordinary course of business.” The must report to both you and DMD/OHT7-OIR/OPEQ/CDRH “any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of your product of which they become aware.”
2. The healthcare providers who prescribe to the COVID-19 testing kit must report all the tests results from patients who use their products to all relevant public health authorities in accordance with “local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARSCoV-2 Tests provided by the Centers for Disease Control (available at: https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html).” Healthcare providers will also report to Lucira Health, Inc., when requested by Lucira, how many individuals reported test results compared to how many tests were prescribed

The EUA and Point-of-Care Settings

1. A few additional authorization conditions involve point-of-care settings. These EUA conditions are:
2. Point-of-care settings that use the manufacturer’s product – “must use your product without any deviations from the authorized labeling.”
3. “Point-of-care settings that receive your product must notify the relevant public health authorities of their intent to use your product prior to initiating testing.”
4. Point-of-care settings that use the manufacturer’s COVID-19 testing product should have procedures in place for reporting test results – to public health authorities and to healthcare providers – “as appropriate.” The point-of-care settings must collect data on the testing product’s performance and report any suspected false positive or false negative occurrences and any significant deviations from the established product performance characteristics (that the point-of-care setting is aware of) to DMD/OHT7-OIR/OPEQ/CDRH (via email: [email protected]) and you ([email protected]).

EUA conditions and Lucira Health, Inc., Authorized Distributors, Healthcare Providers and Point-of Care Settings

All entities involved with the testing kit product must comply with the following condition.

1. The entities must ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.

Conditions Related to Printed Materials, Advertising, and Promotion

The FDA Emergency Use Authorization for the COVID-19 testing product also requires the following:

1. “All descriptive printed matter, advertising, and promotional materials, relating to the use of your product shall be consistent with the authorized labeling, as well as the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations.”
2. None of the described printed matter, advertising, or promotional materials, relating to the use of the testing product can “represent or suggest that this test is safe or effective for the detection of SARS-CoV-2.”
3. The publication materials, relating to product usages should “clearly and conspicuously state that:
   1. This home test kit has not been FDA cleared or approved.
   2. This home test kit has been authorized by FDA under an EUA.
   3. This home test kit has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
   4. This home test kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.”

FDA states in the EUA approval letter that the emergency use of the product must meet the conditions and all other terms set forth in the letter.

The length of the EUA

FDA also states that the EUA is “effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.”

The Food and Drug Administration is beginning to approve medical products such as testing kits and vaccines to help diagnose and treat COVID-19. There are numerous compliance issues that must be met to seek approval. Even when medical products and devices are approved for an FDA EAU, there are many conditions that must be met while the products are being manufactured, distributed, and used.

Medical product and device manufacturers should contact Cohen Healthcare Law Group, PC for legal advice on FDA emergency use authorization, any other type of FDA approval, and any related compliance issues. Our experienced healthcare attorneys advise biotechnology and life science companies, digital health companies, and a full range of health companies and medical practices.