The article provides additional details regarding the approach to be applied with respect to certain types of medical devices in terms of regulatory flexibility. Table of Contents Introduction The Food and Drug Administration (FDA), a Philippines regulatory agency in...
The new article addresses the aspects related to the design considerations for diagnostic clinical performance studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
The new article addresses the aspects related to warnings and precautions to be included in medical device patient labeling. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
The article provides additional details regarding the medical device patient labeling. In particular, it describes the requirements regarding the appearance of text and graphics. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
The article provides an overview of the applicable regulatory requirements in the sphere of labeling for medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
The new article describes in detail one of the regulatory pathways to be used in case of changes to an already marketed medical device – a 30-day supplement. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
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