COVID-19
The article provides an overview of the key provisions of the draft guidance documents dedicated to neonatal products. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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...
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...
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...
COVID-19
The new article highlights the key points related to regulatory requirements for modifications to medical devices allowed for marketing and use. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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)...
