| Coronavirus Disease 2019 (COVID-19) updates  Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include: - March 9, 2021; COVID-19 Update included the first FDA-authorized molecular non-prescription, at-home test
- March 5, 2021: COVID-19 Update included FDA issuance of several warning letters to certain firms offering unapproved, uncleared and unauthorized thermal imaging systems for sale
- March 5, 2021: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test
- March 5, 2021: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test
- March 5, 2021: Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
- March 5, 2021: New Health Equity Forum podcast episode - Health Fraud & COVID-19: What You Need to Know
- March 4, 2021: FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale
- March 4, 2021: FDA Voices: Elastomeric Respirator Innovations Play a Critical Role in Response to COVID-19
- March 3, 2021: FDA in Brief: FDA Calls on Certain Firms to Stop Producing and Issuing Misleading "FDA Registration Certificates"
- March 2, 2021: FDA voices: National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams
Bookmark www.fda.gov/coronavirus for the latest. | | |  COVID-19 vaccine updates COVID-19 vaccination and the food and agriculture sector FDA has been doing what we can to support a safe and ample food supply, but that would not be possible without millions of men and women working in food and agriculture jobs. Day in and day out, they have answered the call as essential workers in support of the food supply. We thank them. FDA has a web page with information for the food and agriculture sector about: - the safety and effectiveness of COVID-19 vaccines authorized for emergency use by the FDA
- benefits of COVID-19 vaccination
- information about the availability of vaccines in your community
COVID-19 alert: Beware of misleading registration certificates  How to tell if a device is approved, cleared, or authorized by the FDA
During the COVID-19 pandemic, some companies are selling medical devices (including masks, respirators, and face shields) using misleading "FDA registration certificates." The registration certificates usually look like official government documents, often displaying the FDA logo. The FDA does not issue any type of registration certificates to medical device firms. Accordingly, the FDA has asked the firms that issue such registration certificates to stop issuing them. (An example of a certificate is pictured to the right.) These registration certificates may mislead consumers to believe a device was reviewed, approved, cleared, or authorized by the FDA. Is a device FDA approved, cleared, or authorized?
In response to an increase in the use of misleading FDA registration certificates during the COVID-19 pandemic, the FDA has developed a new web resource for consumers: Are there "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved? This page provides easy-to-follow instructions to check if the FDA has approved or cleared a device – or if the FDA authorized the device for emergency use during a public health emergency, like COVID-19. To report the suspected misuse of registration certificates, please visit the Reporting Allegations of Regulatory Misconduct page. |  |
| | Emergency Use Authorization (EUA) updates  FDA authorizes first molecular non-prescription, at-home test FDA issued an EUA (PDF) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription. Read more (March 5, 2021) FDA authorizes another tool to identify if a person had a previous COVID-19 infection FDA issued an EUA (PDF) to Adaptive Biotechnologies for its T-Detect COVID Test. The T-Detect COVID Test: - Analyzes DNA from a patient's T cells (white blood cells) to aid in identifying people with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection.
- Should be used together with a clinical examination and a patient's medical history. Negative results do not rule out acute or current SARS-CoV-2 infection.
- Should not be used to diagnose current SARS-CoV-2 infection.
- Is authorized for use in laboratories designated by Adaptive Biotechnologies Corporation that meet requirements to perform high-complexity tests. Read more (March 5, 2021)
New web page: CDER scientific review documents supporting EUAs To promote public confidence in FDA's scientific review process and in ultimately appropriately using products authorized for emergency use, CDER is disclosing information from our scientific review documents supporting EUA for drug and biological therapeutic products as appropriate and consistent with our longstanding practice of posting scientific reviews after new drug and biological product approvals. (March 5, 2021) Diagnostic test EUAs As of today, 340 tests and sample collection devices are authorized by FDA under EUAs. These include 253 molecular tests and sample collection devices, 72 antibody and other immune response tests, and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, one over-the-counter (OTC) at-home antigen test, and one OTC molecular test. Also see: Coronavirus Testing Basics | | | Events - Today! March 10, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - During the virtual town hall for SARS-CoV-2 test developers, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA will host additional webinars in this series on March 17, 24, and 31, 2021.
- Today! March 10, 2021: Precisely practicing medicine for COVID, from a half million tested patients and a trillion points of data (Zoom webcast), 3:00 - 4:00 p.m. ET - This Center of Excellence in Regulatory Science and Innovation (CERSI) lecture is presented by Atul Butte, MD, PhD, University of California, San Francisco (UCSF) -Stanford CERSI. Registration is not required.
- New! March 11, 2021: FDA Grand Rounds webcast - Studies of SARS-CoV-2 NSP1 and Envelope Protein - 12:00 - 1:00 p.m. ET - Presented by Marli Azevedo, Ph.D., Research Biologist, NCTR. Please register in advance.
- March 12, 2021: 365 Days and Counting: COVID-19's Impact on the Oncology Community Zoom webinar, 11:00 a.m. - 12:00 p.m. ET, hosted by the FDA Oncology Center of Excellence. Please register in advance.
- May 26-27, 2021: Save the date! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year's keynote speaker is NIAID Director Anthony Fauci, MD.
| | Information for industry FDA's Data Modernization Action Plan: Putting data to work for public health -
With the near ubiquity of interconnected smartphones and computers in modern life, it can be difficult to remember just how quickly our familiarity with data has evolved. Data, in digital form, seem to be everywhere we look. Yet, we are still at an early stage in our ability to apply data to understand and treat disease and address other public health challenges. At this early stage, even small advances in our ability to gain useful insights from data can represent significant opportunities. In September 2019, when we announced the FDA's Technology Modernization Action Plan (TMAP, PDF) we spoke about the ways that the FDA is modernizing our approach to the use of technology for the agency's regulatory mission, such as in the review of medical product applications and food safety, and other critical functions. Data modernization is the next step in the agency's overhaul of its approach to technology and data, and we are pleased today to announce the Data Modernization Action Plan (DMAP). Read more Guidance for industry FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 70 COVID-19-related guidances to date. | | In case you missed it  FDA is vigilant in protecting consumers against COVID-19 vaccine scams Consumers should know the COVID-19 vaccines that the FDA has authorized for emergency use cannot be sold online. Legitimate COVID-19 vaccines are being distributed for free. Learn more |  List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 225 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list. | Did someone forward you this email? Subscribe.
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