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  5. FDA Roundup: April 12, 2022
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FDA News Release

FDA Roundup: April 12, 2022

For Immediate Release:

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

  • On April 8, the FDA cleared Fitbit’s Irregular Rhythm Notifications software intended to be used with certain wrist-worn consumer products to analyze pulse rate data and identify episodes of irregular heart rhythms that may suggest possible atrial fibrillation. Fitbit’s Irregular Rhythm Notifications software is designed to notify the user when an irregular heart rhythm occurs while the user is not moving. It is intended for over-the-counter use. It is not intended to diagnose or treat atrial fibrillation; for use in people under 22 years of age; or for use in individuals previously diagnosed with atrial fibrillation.
  • On April 8, the FDA issued marketing denial orders (MDOs) to Fontem US, LLC for several myblu electronic nicotine delivery system (ENDS) products after determining their applications lacked sufficient evidence that show permitting the marketing of these products would be appropriate for the protection of the public health. Based on the information provided in the applications submitted by Fontem US, LLC for these myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth.
  • On April 7, the FDA released a video titled “Importing FDA-Regulated Products: The Import Process” that provides basic information for importers; foreign suppliers/exporters; and customs brokers on the import admissibility process and what to expect when importing. The video, available on YouTube, supplements available guidance about the FDA’s import admissibility process available through public websites or occasional webinars, industry trainings, and individual communications such as email. Spanish and Mandarin versions will be released shortly. 
  • On April 6, as part of the FDA’s effort to protect consumers, the agency issued a warning letter to operators of one website, due to marketing unapproved and misbranded drugs for treatment of multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.
  • As part of the FDA’s effort to protect consumers, on April 5, the agency issued a warning letter to CofixRx, LLC for selling an unapproved product with misleading COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider. 
  • On April 4-5, the FDA partnered with the Duke-Margolis Center for Health Policy to host the public workshop, “Identifying Key Competencies for Opioid Prescriber Education.” The workshop featured opening remarks by Center for Drug Evaluation and Research Director, Patrizia Cavazzoni, M.D., and focused on identifying gaps in existing opioid prescriber education offerings and core competencies that should be included in educational content for opioid prescribers and other healthcare providers. During the workshop, the FDA identified an urgent need for a unified, national level education program that adequately informs prescribers on managing pain, including but not limited to the proper use of opioid analgesics, as well as recognition and treatment of substance use disorders. 
    Additionally, the agency raised creating a foundational core curriculum for all opioid prescribers nationwide that could be expanded to address specific needs and tailored to medical specialties. The objectives for opioid prescriber education could include: 
    • expanding prescriber educational content to all healthcare providers;
    • creating content that is consistent, science-based, and unbiased; and 
    • creating meaningful engaging content that promotes adaptive learning instead of a redundant “check-the-box” activity.
  • COVID-19 testing updates:
    • As of today, 427 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 293 molecular tests and sample collection devices, 84 antibody and other immune response tests and 50 antigen tests. There are 74 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 925 revisions to EUA authorizations.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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