FDA Roundup: April 18, 2023

FDA News Release

• For Immediate Release: April 18, 2023

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

• On Monday, the FDA granted marketing authorization to the NTX100 Tonic Motor Activation (NTX100 ToMAc) System to reduce the symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and improve sleep quality among drug-resistant RLS patients. The NTX100 ToMAc is a non-invasive system that includes two separate therapy units and two separate electrode patches that are placed below the knees to provide high-frequency, low-level electrical stimulation to the peroneal nerves that supply movement and sensation to the lower legs, feet and toes. The patient can start or stop the stimulation, adjust intensity, or read battery status via a simple user-interface on the therapy units. The prescribing clinician can calibrate therapy output specific to each patient using a Clinician App. The Clinician App is used exclusively in the clinic and by the clinician. The NTX100 ToMAc is a prescription-use only device. It received Breakthrough Device designation in 2020.
• On Monday, the FDA’s Center for Drug Evaluation and Research (CDER) released a CDER Conversation about its Office of New Drugs’ Research Program. In this CDER Conversation, Laura Jaeger, PhD, associate director of the Research Program, talks about the program’s important work in enhancing regulatory science research. 
• COVID-19 testing updates: 
  • As of today, 446 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, 61 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 46 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1349 revisions to EUA authorizations.