FDA Roundup: March 10, 2023

FDA News Release

• For Immediate Release: March 10, 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 issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents the FDA is revising to temporarily continue in effect.
• This notice follows an announcement from the U.S. Department of Health and Human Services that, based on current COVID-19 trends, the Department is planning for the COVID-19 PHE declared under the PHS Act to expire on May 11, 2023.
• Since the start of the COVID-19 PHE declared under the PHS Act, the FDA has been committed to providing timely recommendations and regulatory information to support response efforts. 
• During the COVID-19 PHE declared under the PHS Act, the FDA has provided important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders. 
• Importantly, the ending of the PHE declared under the PHS Act will not impact the FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met.
• The FDA remains committed to providing notice and information to all impacted stakeholders to ensure a smooth transition.
• Today, the FDA’s Center for Food Safety and Applied Nutrition announced the status of 10 guidance documents that provide temporary flexibility to the food industry during the COVID-19 PHE declared under the PHS Act. These guidance documents will no longer be in effect when the PHE expires; are being temporarily extended and then will no longer be in effect 180 days after the PHE expires; or are being temporarily extended and then revised. Based on current COVID-19 trends, the Department is planning for the COVID-19 PHE declared under the PHS Act to expire on May 11, 2023.
• On Wednesday, the FDA granted marketing authorization of the Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set, intended for prescription use only for the detection of the COVID-19 virus within 6 days of symptom onset and which can be used in a point-of-care setting. The test aids in the diagnosis of COVID-19 for people experiencing symptoms and is to be repeated twice over three days with at least 48 hours between tests. 
• “Today’s marketing authorization of the first COVID-19 antigen test underscores our ongoing commitment to maintain access to testing long-term,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We look forward to working with developers of all test types who are interested in moving their products through our traditional review pathways and encourage those who are ready to do so as soon as possible. We remain committed to ensuring the public has access to accurate and reliable tests they can count on.” 
• Along with this De Novo authorization, the FDA is establishing criteria called special controls that define certain requirements including required labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new, Class II regulatory classification for simple devices to directly detect SARS-CoV-2 viral targets from clinical specimens in point-of-care settings or at home use, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
• On Wednesday, the FDA provided an update on reports of squamous cell carcinoma (SCC) in the capsule around breast implants. The FDA is aware of 19 cases of SCC in the capsule around the breast implant from published literature. While the FDA continues to believe that occurrences of SCC in the capsule around the breast implant may be rare, health care providers and people who have or are considering breast implants should be aware that cases of SCC and various lymphomas in the capsule around the breast implant have been reported to the FDA and in the literature. The FDA continues to ask health care providers and people with breast implants to report cases of SCC or any other cancers around breast implants to the FDA.

 

• On Wednesday, March 15, C-Path will host a webinar about its Critical Path for Rare Neurodegenerative Diseases (CP-RND) public-private partnership. The webinar will share an overview of CP-RND to the patient stakeholder group and provide the opportunity for feedback and questions from participants. CP-RND is a public-private partnership with FDA and NIH aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases. More information and registration are available on C-Path’s webinar page.    
• 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 1288 revisions to EUA authorizations.