Why you should not use ivermectin to treat or prevent COVID-19 | Beware of misleading registration certificates | New COVID-19 tests authorized

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.

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. 

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  

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.

FDA's COVID-19 response

See the updated FDA COVID-19 Response At-A-Glance Summary (PDF) for a quick look at facts, figures and highlights of the agency's response efforts. (updated February 28, 2021)