WARNING LETTER
Physician 360, Inc.
MARCS-CMS 604202 —
October 05, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Dr. Rob Lapporte
Recipient Title
Co-Founder and CMO
Physician 360, Inc.
1104 Lake Carillon Lane
Southlake
,
TX
76092
United States
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
October 5, 2020
Dear Dr. Lapporte:
The Food and Drug Administration (FDA) has learned that your firm is manufacturing and marketing the Physician 360 Rapid Strep Test, Physician 360 Rapid Flu Test
(
collectively referred to as Physician 360 Rapid Tests), and Physician 360 COVID-19 Rapid Test in the United States without marketing clearances or approvals, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Physician 360 Rapid Tests
The FDA has reviewed your
firm’s website
(
https://www.physician360.co/
), which indicated that your firm’s Physician 360 Rapid Tests may be purchased directly by consumers and are intended to be used for at-home testing by lay users.  For example, your website contains the following statements and information demonstrating your devices are test kits intended for use in the diagnosis of Group A Streptococcal infection (Strep A) and Influenza A and B viral infections at home by lay users:
“Test yourself for the flu in 2 simple steps!” (www.physician360.co/flu) and “Test yourself for strep in 2 simple steps” (www.physician360.co/strep).
[1]
The video available at https://physician360.co/shop/flu-kit-with-physician-consult/ contains instructions which show the user how to self-collect a sample, perform the test, and read/interpret the test results.
Instructions for Use (IFU) for the Physician 360 Rapid Strep and Rapid Flu tests available via https://www.physician360.co/flu and https://www.physician360.co/strep provide instructions for users on how to self-collect a sample or collect a sample from a child.
The Agency is not aware of either a test to identify streptococcal infection, or a test to identify influenza infection, intended to be used for at-home testing by lay users, that is legally marketed for that use.  Therefore, FDA has determined that the Physician 360 Rapid Strep Test and the Physician 360 Rapid Flu Test are Class III devices under section 513(f)(1) of the Act, 21 U.S.C.
§ 360c(f)(1) and require premarket approval
.
Because your firm does not have, for either test, 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), the Physician 360 Rapid Tests are therefore adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B).  The Physician 360 Rapid Tests are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce each device into interstate commerce for commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
[2]
In prior correspondence with FDA, you have stated that you believe that the Physician 360 Rapid Tests may be legally marketed because the Physician 360 Rapid Strep Test incorporates the previously-cleared QUIDEL QuickVue In-Line Strep A Test
[3]
and the Physician 360 Rapid Flu Test incorporates the previously-cleared BioSign Flu A+B test.
[4]
You contend that your devices “are operating under the already established 510(k) clearance [sic].”  However, because you have modified the previously-cleared devices you identify in your responses and incorporated them into new devices with different intended uses manufactured by your firm, the previously-cleared devices are not considered to be the same devices as the Physician 360 Rapid Tests.  For example, to manufacture the Physician 360 Rapid Tests you remove and replace the original manufacturer’s labeling with your own labeling with new instructions for performing the tests at home by lay users.
[5]
In addition, there are significant differences between the Physician 360 Rapid Tests and the previously-cleared devices you referenced in your prior correspondences.  For example, both of the previously-cleared test kits you identified in your correspondence with FDA were cleared by the Agency for use only in professional healthcare settings by healthcare professionals and are not intended for home use by lay users.
In your correspondence with FDA, your firm has also argued that you are a telemedicine service and that your firm’s activities are considered practice of medicine. For the reasons set forth above, the FDA has determined your firm is the manufacturer of the Physician 360 Rapid Tests and is marketing those unapproved devices to consumers.  Although section 1006 of the Act (21 U.S.C. § 396)  states that “[n]othing in [the Act] shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient within a legitimate health care practitioner-patient relationship” that section does not affect the Act’s prohibition on the marketing of unapproved devices and, as set forth above, the Physician 360 Rapid Tests are currently unapproved and require premarket review and approval by FDA prior to marketing.
Your firm should immediately cease commercial distribution of the Physician 360 Rapid Tests and take prompt action to correct the violations addressed in this letter.  This action is necessary to prevent health risks associated with home use of your tests by lay users.  The most immediate risk is injury to the user during sample collection.  Other significant health risks include false negative results due to inexperienced users using the device, potentially leading to a delay in an individual receiving effective treatment for strep throat (Group A Streptococcal infection) or influenza. For both Group A Streptococcal infection or influenza, correct diagnosis and delay in treatment can lead to an increased risk of complications. The likelihood of an individual spreading infection, particularly influenza, is increased in the setting of falsely negative results.
This letter is not meant to be an all-inclusive list of the 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.  Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
Also, f
ederal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations regarding the Physician 360 Rapid Tests, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken,  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.  If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Physician 360 COVID-19 Rapid Test
Furthermore, the FDA reviewed your website at the Internet address https://physician360.co/ on August 14, 2020. The FDA has observed that your website offers the “Physician 360 COVID-19 Rapid Test” for sale in the United States directly to individual healthcare providers for self-use with capillary blood.  Based on our review, this product is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of
COVID-19
[6]
in people, and thus, is a device under section 201(h) of the Act.
The Physician 360 COVID-19 Rapid Test is offered for sale and distributed in the United States directly to consumers (specifically, individual healthcare providers) for self-use with capillary blood without marketing approval, clearance, or authorization from FDA.
[7]
Accordingly, this 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.
[8]
In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.
[9]
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 product for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Your website,
https://www.physician360.co/
, indicates that your firm’s Physician 360 COVID-19 Rapid Test may be purchased directly by consumers for self-use with capillary blood, including:
“I am a healthcare provider & worried I’ve been exposed to coronavirus.  Purchase to prescription in less than 30 minutes.  Get an immediate test result, telemedicine consult, diagnosis and treatment!”
An instructional video on your website displays what appears to be a person self-administering the Physician 360 COVID-19 Test using capillary blood from a fingerstick and interpreting the results of the test.
“This blood test analyzes a small blood sample, from a finger stick.”
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)”
[10]
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 regarding the Physician 360 COVID-19 Rapid Test. This letter is not meant to be an all-inclusive list of violations that exist in connection with your product 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 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 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 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 regarding the Physician 360 COVID-19 Rapid Test to FDA at COVID-19-Task-Force-CDRH@fda.hhs.gov.
Sincerely yours,
/S/
Timothy Stenzel, M.D., Ph.D.
Director
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Office of Product Evaluation and Quality
Center for Devices and Radiological Health
[1]
The physician360 website (www.physician360.co) was last visited on July 27, 2020.
[2]
For a device requiring premarket approval, the notification required by section 510(l) is deemed satisfied when a PMA is pending before the FDA.
See
21 CFR 807.81(b).
[3]
Even though your listing in the FDA’s Registration and Listing Database does not list a device, information you submitted to FDA indicates that your Physician 360 Rapid Flu Test incorporates the device cleared under K934484.  Regardless of which previously-cleared device you may be incorporating into your Physician360 Rapid Strep Test, your device is subject to premarket approval requirements for the reasons set forth in this letter.
[4]
Note that the BioSign Flu A+B test device was originally cleared by FDA under K083746 and later followed by three special 510(k) clearances under K132465, K133474 and K182157.  Regardless of which previously-cleared device you may be incorporating into your Physician360 Rapid Flu Test, your device is subject to premarket approval requirements for the reasons set forth in this letter.
[5]
Under 21 CFR 807.3(d), the definition of the term “manufacture” includes the activity of “[r]epackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer.”  Note that your firm does not dispute that it is a repackager/relabeler as is presently registered as a repackager/relabeler in FDA’s Device Registration and Listing Database.  However, as an entity engaged in manufacturing, including repackaging and relabeling , Physician360 is an establishment required to register and list under 21 CFR 807.20.
[6]
As explained below, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
[7]
The “Physician 360 COVID-19 Rapid Test” offered for sale on your website appears to incorporate the RightSign COVID-19 IgG/IgM Rapid Test Cassette manufactured by Hangzhou Biotest Biotech Co., Ltd.  On June 4, 2020, FDA issued an Emergency Use Authorization (EUA) pursuant to section 564 of the Act, 21 U.S.C. § 360bbb-3, to permit emergency use of the RightSign COVID-19 IgG/IgM Rapid Test Cassette by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the requirements to perform moderate or high complexity tests for the qualitative detection and differentiation of IgM and IgG antibodies against SARS-C0V-2 in human serum, plasma, and venous whole blood (sodium heparin, potassium EDTA, and sodium citrate).  However, this EUA does not authorize the sale of the RightSign COVID-19 IgG/IgM Rapid Test Cassette directly to consumers for self-use with capillary blood.
[8]
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).
[9]
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/).
[10]
Accessible
at https://www.fda.gov/media/135659/download.
Content current as of:
11/03/2020
Regulated Product(s)
Medical Devices