FDA
The article provides an overview of the regulatory requirements related to the actions to be taken by the authority and/or applicant in the context of premarket notification, and the effect such actions will have on the review timelines. Table Of Contents: The Food...
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...
FDA
The article provides an overview of the official guidelines dedicated to classification rules and requirements for medical devices intended to be marketed and used in the US. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating...
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...
FDA
The new article covers the matters related to antigen diagnostic tests and explains the approach to be applied by the test developers in order to ensure the continued effectiveness of their devices. Table Of Contents: The Food and Drug Administration (FDA or the...
