FDA Roundup: March 24, 2023

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

• Today, the FDA finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). You can read the CDRH Statement here.
• These guidances outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations. The recommendations include information for devices that fall within certain enforcement policies issued during the COVID-19 public health emergency (PHE) under section 319 of the Public Health Service Act and devices issued EUAs related to COVID-19 under section 564 of the Federal Food, Drug, and Cosmetic Act, including: 
  • Developing a transition implementation plan,
  • Submitting a marketing submission, and
  • Taking other actions with respect to these devices.
• There will be a 180-day transition period for impacted devices to help avoid disruption in device supply and help ensure an orderly and transparent transition (specific information on the scope and the timeline for the transition period can be found in each guidance). The FDA encourages stakeholders to plan for the transition process by reviewing the two final guidances, attending the upcoming webinar, and contacting the FDA if they have questions. If manufacturers with impacted devices plan to continue distributing their devices after either the end of the transition period following the expiration of the COVID-19 PHE or termination of the relevant device EUA declaration related to COVID-19, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
• Today, the FDA issued a press release FDA Takes Additional Steps to Improve Nutrition, Reduce Disease with Expanded Use of Salt Substitutes to Help Lower Sodium Intake and an accompanying Constituent Update. The proposed rule would change standards of identity for foods that include salt to permit the use of safe and suitable salt substitutes.  The proposed rule would help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods to reduce sodium content, in the same manner that is already possible for non-standardized foods. This has the potential to contribute to better health outcomes by helping consumers to gradually reduce their sodium intake. The proposed rule is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health.  
• Today, the FDA issued a press release FDA Works to Further Improve Nutrition, Reduce Diet-Related Chronic Disease with Dietary Guidance Statements on Food Labels and accompanying Constituent Update. The draft guidance provides food manufacturers with recommendations on how and when to use Dietary Guidance Statements on the label of food products to ensure the label statements promote good nutrition, provide greater consistency in labeling, and help consumers in making informed choices. The guidance is part of the FDA’s overall goal to help reduce the burden of chronic disease and advance health equity and is also part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health. 
• Today, the FDA announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2023 in a Federal Register Notice (FRN) titled “Over-The-Counter Monograph Drug User Fee Rates for Fiscal Year 2023.” This FRN publishes fees for OTC monograph drug facilities and OTC Monograph Order Requests (OMORs) for FY 2023. The FRN includes information about facility fee calculations, OMOR fee calculations, fee due dates, and fee payment procedures. OTC monograph drug facility fees for FY 2023 are due June 1, 2023.
• On Thursday, the FDA released the Framework for the Use of Digital Health Technologies (DHT) in Drug and Biological Product Development to guide the Agency’s multifaceted DHT program for drugs and biological products. The program will engage stakeholders and include workshops and demonstration projects; establish internal processes to support DHT evaluation for use in drug development; promote shared learning and consistency for DHT-based policy, procedure, and analytic tool development; and facilitate the publication of relevant guidance documents. For information on the DHT program, please visit the Digital Health Technologies for Drug Development webpage.
• On Tuesday, the FDA released the Activities for the Safety of Imported Seafood. The report shares the comprehensive approach the FDA is taking to ensure that imported seafood consumed in the U.S. meets food safety requirements and the standards of domestically produced seafood.
• On Tuesday, the FDA released new educational materials to educate patients about biosimilars, including materials specifically for patients with diabetes – two fact sheets: Biosimilars What Patients Need to Know, Biosimilars What Patients with Diabetes Need to Know, and an infographic: Biosimilar Basics Infographic for Patients. The materials for patients are also available in Spanish: Biosimilares: Lo Que los Pacientes Deben Saber, Biosimilares: Lo Que los Pacientes con Diabetes Deben Saber, and Conceptos Básicos Sobre los Biosimilares. For more information about biosimilars and additional resources for patients, please visit the newly redesigned Basics for Patients webpage.
• COVID-19 testing updates: 
  • As of today, 445 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 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 1317 revisions to EUA authorizations.

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