- Medical Devices
- Issuing Office:
- Center for Devices and Radiological Health
Date: June 17, 2020
email@example.com – George Masey
Modern Allergy Management dba
Direct Med Solutions
3103 Glasgow Ct.
Milton, FL 32583
CC: info@KBMODiagnostics.com – James White, CEO
KBMO Diagnostics, LLC
4 Business Way
Hopedale, MA 01747
RE: Adulterated and Misbranded Products Related to Coronavirus Disease 2019
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://covid.directmedsolutions.com/fingerstick on June 16, 2020. FDA has observed that your website offers an at-home sample collection kit that can be sent to KMBO Diagnostics, LLC for COVID-191 serology testing, specifically the “COVID-19 Fingerstick Test Kit.” 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 Fingerstick Test Kit” 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 HHS2. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-193. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval, clearance, 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 of COVID-19 in people. We request that you take immediate action to cease the sale of such unapproved, uncleared, and unauthorized products for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Different and potentially serious public health risks are presented with sample collection in the home versus a healthcare setting. Such risks may include, but are not limited to, whether a lay user can safely and properly collect the specimen; whether the components of the specimen transport media are safe for use in the home environment; adequate stability of the specimen given the time lapse between collection and testing; proper shipment; and the potential impact of shipping conditions on the sample. Your website, https://covid.directmedsolutions.com/fingerstick states that your product is intended to be used for at-home blood sample collection for COVID-19 serology testing, including the following:
o “Get your COVID-19 Fingerstick test sent right to your home and mail it back to our lab for COVID-19 antibody analysis. Your sample will go through our rigorous lab testing and you will receive your results via email within 48-72 hours.”
o “3 Easy Steps To Get Test Kit. 1. Please Order Online And Receive The Fingerstick Kit. This is a kit that will be shipped directly to your house. 2. Review Instructions And Perform Procedure. The kit will come with instructions, blood spot card, biohazard bag, alcohol prep pad, sterile single-use lancet, prepaid mailing envelope, and a patient requisition form. 3. Receive Your Results Via Email. Your sample will be shipped back overnight to our lab. You will receive your results within 48-72 hours.”
o Your website includes a video titled, “COVID-19 Fingerstick Test,” demonstrating how to self-collect a blood sample at home and providing directions for mailing the sample to KMBO Diagnostics, LLC.
o “Order Your At-Home Test Kit for COVID-19 Antibodies”
Your product is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because your webpage uses the FDA logo. The FDA logo is for the official use of the FDA and not for use on private sector materials. Such use may send a misleading message that the FDA favors or endorses your product. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.
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)4” 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 take 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, or 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 that 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 product is not in violation of the 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
- 1. As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
- 2. 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 was renewed for another 90 days on April 21, 2020. Secretary of Health and Human Services Alex M. Azar II, Renewal of Determination that a Public Health Emergency Exists. April 21, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-21apr2020.aspx).
- 3. 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/).
- 4. Accessible at https://www.fda.gov/media/135659/download