FDA Roundup: March 7, 2023

FDA News Release

• For Immediate Release: March 07, 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 Letter to Health Care Providers about our expanded work to evaluate the potential risk of exposure to toxic compounds when using hemodialysis and peritoneal dialysis systems that have parts made of chlorinated peroxide cured silicone. The FDA recognizes that hemodialysis and peritoneal dialysis systems are critical to patient care. The FDA is working with manufacturers to further collect and evaluate data to determine the potential risk of exposure to toxic compounds on patients and develop strategies to address the issue, if needed.
• On Monday, the FDA unveiled its new Dietary Supplement Ingredient Directory, a webpage where the public can look up ingredients used in products marketed as dietary supplements to quickly find what the FDA has said about that ingredient and whether the agency has taken any action with regard to the ingredient. The directory is in list form and includes links to the agency’s actions and communications for each ingredient on the list. If there is a separate FDA webpage for the ingredient, the directory links to that page. The directory is intended to be a one stop shop of ingredient information that was previously found on different FDA webpages. This directory is intended to help manufacturers, retailers, and consumers stay informed about ingredients that may be found in products marketed as dietary supplements and quickly locate information about such ingredients on the FDA’s website.
• On Monday, the FDA revised and reissued the umbrella Emergency Use Authorization (EUA) for disposable, single-use surgical masks intended for use in health care settings by healthcare professionals during the COVID-19 pandemic. The revision authorizes emergency use of only those surgical masks listed in the EUA’s Appendix A as of the date of this reissuance. As a result of this revision, the FDA will no longer be adding surgical mask models to Appendix A. Manufacturers who would like to bring new surgical masks to market should follow traditional premarket pathways, such as a premarket notification, or 510(k). Manufacturers can refer to the FDA’s guidance on surgical masks for further information.
• On Friday, the FDA cleared the first device authorized under the FDA’s Safer Technologies Program. This device, the Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) (510(k) Premarket Notification (fda.gov)), is intended for use during gastric and bariatric surgical procedures to provide fluorescence-guided visualization of the tube position, to serve as a sizing and measurement guide during gastric resection, to facilitate stomach decompression, drainage of gastric fluids, and testing for staple line leaks. Launched in January of 2021, the FDA’s Safer Technologies Program is a voluntary program for certain medical devices and device-led combination products that have the potential to be safer than currently available treatments or medical diagnostics. The program is intended to help patients have more timely access to products by expediting their development, assessment, and review, while maintaining FDA’s standards for safety and effectiveness, data requirements, and quality of review.
• 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 1274 revisions to EUA authorizations.