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FDA Roundup: February 8, 2022
Dear International Colleague,
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA warned health care providers, parents and caregivers of pediatric patients (children) who receive enteral feeding that there is a risk of strangulation from the sue of enteral feeding delivery sets. The feeding set tubing can become wrapped around a child’s neck and cause strangulation or death. The FDA has received reports of two toddlers who died after being strangled by the tubing.
- The FDA Center for Drug Evaluation and Research and the FDA Biomarker Working Group has announced a virtual workshop on March 23-24 from 1-3 p.m. titled, Identification of Concepts and Terminology for Multi-Component Biomarkers. The workshop is intended to develop multi-component biomarker concepts and terminology, identify areas of conceptual language development through presentation of use cases, and discuss gaps in terminology for concepts and approaches related to multi-component biomarkers.
- Today, the FDA issued a guidance for industry and investigators titled “COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation Tunnels” to announce a policy discouraging sponsors from developing or seeking approval or authorization for the use of sanitation tunnels, which are tunnels, walkways, chambers, and similar systems, that spray humans with a mist of disinfectant or aerosolized antiseptic with the aim of preventing or treating COVID-19.
- On Feb. 4, the FDA warned people not to use the E25Bio COVID-19 Direct Antigen Rapid Test (DART). This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the FDA. The E25Bio COVID-19 Direct Antigen Rapid Test (DART) may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit. The FDA is concerned about the risk of false results when using this test because E25Bio has not provided the FDA with adequate data demonstrating that the test’s performance is accurate. In addition, the FDA is aware that the E25Bio COVID-19 Direct Antigen Rapid Test (DART) was sold directly to consumers and may have been accompanied by labeling with instructions for collecting a sample from deep inside the nose, reaching the back of the throat (nasopharyngeal) or from the middle part of the throat (pharynx) just beyond the mouth (oropharyngeal), which could result in serious injury when this is not done by trained professionals. The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the E25Bio COVID-19 Direct Antigen Rapid Test.
- On Feb. 4, the Center for Devices and Radiological Health’s Digital Health Center of Excellence provided updates about its ongoing work to empower digital health stakeholders by promoting awareness, transparency, and consistent application of digital health regulatory policies; pioneering the development and enhancement of digital health regulatory paradigms; and fostering digital health-focused collaborations.
- COVID-19 testing updates:
- As of today, 421tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 291 molecular tests and sample collection devices, 85 antibody and other immune response tests and 45 antigen tests. There are 69 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, three EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 26 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 812 revisions to EUA authorizations.
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