For Immediate Release:

FDA Roundup: October 21, 2022

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

  • On Thursday, the FDA issued a draft guidance, “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care.” The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity. It also proposes updates to clarify considerations in designating devices, including eligible devices that may benefit populations impacted by disparities in health and health care, as well as how the FDA discloses the Breakthrough status of designated devices once they receive marketing authorization.  

“The FDA is committed to advancing the development of safe and effective technologies to meet the needs of all patients and consumers,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “This draft guidance, once finalized, can help FDA and our stakeholders leverage the interactive nature of the Breakthrough Devices Program to move us closer to achieving our new Strategic Priority to Advance Health Equity, where technologies, including digital health technologies, can help advance better health care, quality of life, and wellness for all communities, and meet the needs of diverse populations.” 

  • On Thursday, the FDA issued the final guidance on the Refusal of Inspection by a Foreign Food Establishment or Foreign Government that describes the actions, behaviors, and statements by a foreign food establishment or foreign government that the FDA considers to be a refusal of an FDA inspection. Food for importation into the United States comes from all over the world. One way that the FDA protects the U.S. food supply is by conducting inspections of foreign food facilities to identify potential food safety concerns.  
  • On Wednesday, the FDA issued final guidance #253, “Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products” and final guidance #254, “Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products.” The guidance documents are intended to support the development of promising and innovative products that can benefit animal health by providing product-specific recommendations that will help developers of these products meet existing FDA manufacturing requirements. The FDA incorporated public input on the draft guidance documents after they published for public comment in September 2021. 
  • On Wednesday, the FDA announced it would extend the public comment period for the Sept. 30 notice of the 2022 public meeting and comment period on reauthorization of the Animal Generic Drug User Fee Act for fiscal years 2024 through 2028 (AGDUFA IV). Comments on the notice must be submitted by November 14, 2022. The FDA is taking this action due to a delay in the posting of the AGDUFA IV Performance Goals and Procedures Letter. This extension will provide the public 30 days to comment.
  • On Wednesday, the FDA authorized the Novavax COVID-19 Vaccine, Adjuvanted for use as a first booster dose to individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate and to individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine. The vaccine may be administered at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine. This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA. Additional information is available on the agency’s web site.
  • On Wednesday, the FDA announced the Advancing Real-World Evidence (RWE) Program, which provides sponsors selected into the program the opportunity to meet with Agency staff to discuss the use of RWE in medical product development. The program is designed to improve the quality and acceptability of RWE-based approaches to meet regulatory requirements in support of labeling for effectiveness or for meeting post-approval study requirements.  
  • On Monday, the FDA authorized for marketing the ScanNav Anatomy Peripheral Nerve Block, a software as a medical device that can identify anatomical structures within ultrasound images to help anesthetists and other qualified healthcare professionals before needle insertion when performing ultrasound-guided regional anesthesia procedures. The software identifies anatomical structures by using deep learning artificial intelligence technology. The ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems and is intended to be used in patients 18 years of age or older.


  • The FDA recently announced that it will hold two connected public workshops to promote medical device innovation relating to development and monitoring devices for patients using opioids and risk prediction devices of opioid use and opioid use disorder on November 7-8, 2022 in partnership with the National Institutes of Health (NIH). The FDA’s Center for Devices and Radiological Health remains committed to addressing this national crisis by encouraging and fostering the development of innovative medical devices to help individuals who use opioids and to help reduce the need for opioids.  
  • COVID-19 testing updates:
    • As of today, 437 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
    • The FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1136 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.