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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance...
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Feb 2, 2023
FDA
The article describes the approach to be applied with respect to viral mutations and their potential impact on the performance of tests intended to identify the virus. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority...
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Feb 2, 2023
COVID-19
The new article highlights the aspects related to the use of tests developed by certified laboratories, as well as the ones being reviewed by the authority. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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Feb 2, 2023
FDA
The new article provides an overview of the revised guidance document and outlines the key points associated thereto. 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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