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FDA releases AI/Machine Learning Action Plan

The U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. “The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effective software functionality that improves the quality of care that patients receive. To stay current and address patient safety and improve access to these promising technologies, we anticipate that this action plan will continue to evolve over time,” said Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH). The Action Plan can be accessed and downloaded from the FDA website.

Covid-19 diagnostic: An antigen test as over-the-counter fully at-home test

The FDA issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for Covid-19. The Ellume Covid-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. More information can be found on the FDA website.

FDA authorizes first Covid-19 and flu combination test for use with home-collected samples

The U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both Covid-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC Covid-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for Covid-19 +Flu by individuals who are suspected of respiratory viral infection consistent with Covid-19 when home collection is determined to be appropriate by an individual’s healthcare provider. More information can be found on the FDA website.