FDA Roundup: February 28, 2023

SILVER SPRING, Md., Feb. 28, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA is withdrawing the 2005 proposed rule, "Food Standards; General Principles and Food Standards Modernization," in response to comments received in 2005 after publication of the proposed rule and in 2020 after the FDA reopened the comment period for the proposed rule. The proposed rule, jointly published with the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS), was intended, in part, to establish a set of general principles for the FDA and USDA-FSIS to use when considering whether to establish, revise, or eliminate a food standard. A joint FDA and USDA effort to publish a new proposed rule on principles for food standards modernization was included in the Fall Unified Agenda.

• On Monday, the FDA issued a Letter to Health Care Providers to inform health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta valve and Trifecta valve with Glide Technology (GT). Information from published literature suggests a higher cumulative incidence of early SVD for Trifecta valves compared to other commercially available surgical bioprosthetic valves. In addition, the FDA has received reports describing early SVD. The Letter to Health Care Providers includes important information about Abbott Trifecta and Trifecta GT valves, including:
• background on the potential risk of early SVD;
• recommendations for health care providers;
• actions the FDA is taking to address the issue; and
• instructions for reporting problems with these devices.

The FDA is committed to communicating with health professionals and the public to ensure the health and safety of patients in support of our mission to protect and promote public health.

• On Friday, February 24, the FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can identify and tell the difference between influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19. The Lucira COVID-19 & Flu Home Test is a single use test for individuals with signs and symptoms consistent with a respiratory tract infection including COVID-19. As with other OTC COVID-19 tests, the Lucira test can be purchased without a prescription and performed completely at-home.
  
  This test can be used for people:
• Age 14 years or older with a self-collected nasal swab sample.
• Age 2 years of age or older when an adult collects the nasal swab sample.

The Lucira test provides results in 30 minutes or less. The EUA issued for this test represents the FDA's ongoing commitment to increase the availability of appropriately accurate and reliable at-home diagnostic tests, including for COVID-19, and to facilitate access to these tests for all Americans. The collective impact of COVID-19, flu and RSV underscore the importance of diagnostic tests for respiratory viruses, and the FDA recognizes the benefits that at-home testing can provide. The FDA will continue to use its authorities to increase the number of appropriately accurate and easy to use at-home tests available to the public, especially tests that detect these highly contagious respiratory viruses. 

• On Friday, the FDA updated the Breakthrough Devices Program online metrics to add more device designations and marketing authorizations. As of December 31, 2022, the program's new total for devices granted designations is 760 and for devices authorized for marketing is 62. The Breakthrough Devices Program can help provide patients and health care providers with timely access to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

• On Friday, the FDA authorized for marketing the EnteraSense Ltd. PillSense System, a novel device used for the detection of blood in the upper gastrointestinal tract in adults. This system includes a prescription-only, single-use digestible capsule with an optical sensor that detects blood by analyzing the absorption of multiple wavelengths of light and wirelessly transmits data to a receiver. After ingestion, the PillSense Capsule will make its way through the gastrointestinal tract and is then passed naturally through the body. This system is used to supplement other clinical measures to detect blood in patients suspected of having upper gastrointestinal bleeding.

• On Wednesday, the FDA announced that on April 25, 2023, the agency will host a virtual public meeting on Patient-Focused Drug Development for Long COVID. This meeting will provide the FDA with the opportunity to obtain initial patient and patient representative input on the aspects of Long COVID, including how Long COVID affects their daily life, symptoms that matter most to patients, their current approaches to treating Long COVID and what they consider when determining whether to participate in a clinical trial. This virtual public meeting will be conducted with live translation in both English and Spanish. To register, visit the Patient-Focused Drug Development for Long COVID meeting page.

• Each month, the FDA Grand Rounds lecture series highlights a key public health challenge, and how the FDA is applying science and innovation to its regulatory activities. The agency invites you to attend the next presentation on March 9, 2023, from 12 to 1 p.m. ET, on the topic, "Microphysiological Systems as Novel Disease Models and Drug Development Tools." A microphysiological system, or MPS, uses a microscale cell- culture platform to model functions of specific tissues or organs outside of a living organism. The first presentation from the National Center for Toxicological Research in the Office of the Chief Scientist evaluates an MPS model of Zika virus infection which—once developed—might be useful for evaluating potential vaccines and treatments for Zika virus infection using this alternative method. The second presentation will discuss the pros and cons of various liver MPS models and the challenges in using them to help reduce or refine animal tests.

• COVID-19 testing updates:
  
  
• As of today, 444 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 299 molecular tests and sample collection devices, 84 antibody and other immune response tests, 60 antigen tests, and one diagnostic breath test. There are 78 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and five for molecular OTC at-home tests.
• The FDA has authorized 45 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1257 revisions to EUA authorizations.

 Additional Resources: 

• FDA Newsroom 

Media Contact: FDA Office of Media Affairs, 301-796-4540 
Consumer Inquiries: 888-INFO-FDA 

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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SOURCE U.S. Food and Drug Administration