Feb 7, 2023
COVID-19
The new article addresses the matters related to modifications to photobiomodulation devices, provides definitions of the most important terms and concepts used, and also describes warnings and precautions to be included in labeling. Table of Contents The Food and...
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Feb 7, 2023
COVID-19
The new article describes in detail the aspects related to clinical trials, including the determination of study endpoints and duration, as well as follow-up schedule, statistical considerations, and adverse events monitoring. Table of Contents The Food and Drug...
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Feb 7, 2023
COVID-19
The new article covers the general matters related to clinical investigations with photobiomodulation devices involved. 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 7, 2023
FDA
The new article addresses the aspects related to the application of wireless technologies that are widely used in medical devices nowadays, as well as to certain safety-related matters. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
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Feb 7, 2023
FDA
The new article covers the aspects related to usability testing to be conducted, and also to electrical safety and electromagnetic compatibility. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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