The world is being quietly rearranged by people who write very long documents.


The title they went with Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings Noisy translates that to

Simple, rapid COVID tests now have a permanent, faster path to market


US health regulators just moved simple, rapid COVID-19 tests into a lower-risk regulatory class. This means manufacturers can get these specific tests to patients faster and with less paperwork.
During the pandemic, many COVID tests came to market under emergency rules. This new classification creates a permanent, streamlined path for simple, rapid tests. It makes it easier and cheaper for companies to develop and sell these devices for the long term.
Watch how quickly new simple, rapid COVID tests get approved under this new classification, compared to the previous emergency authorization process.

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