Feb 2, 2023
FDA
The new article highlights the key points related to comparison to existing medical devices, as well as the labeling used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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Feb 2, 2023
COVID-19
The article provides an overview of the existing regulatory framework and highlights the key points to be considered. Table of Contents Regulatory Background The present guidance covers the matters related to the 510(k) submissions for photobiomodulation (PBM)...
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Feb 2, 2023
FDA
The new article highlights the aspects related to reprocessing of photobiomodulation devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance...
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