- Medical Devices
- Issuing Office:
- Center for Devices and Radiological Health
Date: August 18, 2020
CC: email@example.com Marc Jablonski – DxAllergy Solutions, LLC
16192 Coastal Hwy
Lewes, DE 19958
RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.elizabethyarnell.com on August 17, 2020. The FDA has observed that your website offers a “COVID-19 test package” for sale in the United States directly to consumers for at-home use. Based on our review, this product is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people, and thus, it is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h).
The “COVID-19 test package” is offered for sale and distributed in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from FDA. Accordingly, your product is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your product is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). The introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a). In addition, it is a prohibited act under section 301(k) of the Act, 21 U.S.C. § 331(k), to do any act with respect to a device while the device is held for sale after shipment in interstate commerce and results in the device being misbranded.
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell a product that is intended for use in the mitigation, prevention, treatment, diagnosis, or cure COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved and unauthorized product for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
We remind you that, to date, FDA has not approved, cleared, or authorized any COVID-19 serology test for at-home testing. Different and potentially serious public health risks are presented with testing in the home versus a healthcare setting. Such risks include, but are not limited to, whether a lay user has the ability to collect their specimen, run the test, and interpret their results accurately. Your website, www.elizabethyarnell.com, indicates that the “COVID-19 test package” may be purchased directly by consumers and is intended to be used for at-home testing for COVID-19, including:
- “NEW! COVID-19 at-home antibody testing kit now available!”
- “COVID-19 Home Testing . . . Whether you are currently ill and wondering, or you were ill but recovered, or suspect you have been exposed to someone who is sick, this FDA-registered test can put your mind at ease instantly, in the comfort of your own home.
- “With just a quick prick using the included spring-loaded finger pricker, you’ll get an immediate positive or negative reading for current infection as well as past exposure.”
- “Click here for more information on the COVID-19 at-home blood test . . . .”
For more information about FDA’s regulation of devices used to mitigate, prevent, treat, diagnose, or cure COVID-19; frequently asked questions; and other helpful resources, visit our website at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19-pandemic. In addition, the guidance titled “Policy for Coronavirus Disease 2019 Tests During the Public Health Emergency (Revised)” provides information about FDA’s policies intended to help expand testing capacity by facilitating the development and use of COVID-19 tests during the public health emergency.
You should immediate action to correct the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your product(s) or operations. It is your responsibility to ensure that the products you sell are in compliance with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your product(s) as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, authorized by FDA and that you do not make claims that adulterate or misbrand the product(s) in violation of the Act. Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.
FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and are being misleadingly represented as safe and/or effective for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19-related products in violation of the Act. This list can be found at https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products. Once you have taken corrective actions to cease the sale of your unapproved, uncleared, and unauthorized product(s) for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.
If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Please direct any inquiries to FDA at COVID-19-Task-Force-CDRH@fda.hhs.gov.
Timothy Stenzel, M.D., Ph.D.
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
 As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
 The “COVID-19 test package” offered for sale on your website appears to be the Novel Coronavirus (SARS-CoV-2) IgM and IgG Dual Combined Antibody Detection Kit for Serum manufactured by RayBiotech Life, Inc. which is currently listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage at https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2. The “removed” test list includes tests where significant clinical performance problems were identified that cannot be or have not been addressed by the commercial manufacturer in a timely manner, tests for which an Emergency Use Authorization (EUA) request has not been submitted by a commercial manufacturer of a serology test within a reasonable period of time as outlined in FDA’s guidance, and tests voluntarily withdrawn by the respective commercial manufacturers. Tests on the “removed” test should not be distributed in the United States unless and until an EUA is issued for the test or the test receives marketing approval or clearance from FDA.
 Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx). The declaration has been renewed for an additional 90 days twice. The most recent renewal went into effect on July 25, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21.aspx).
 President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19). Mar. 13, 2020. (Accessible at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).