FDA
The new article addresses the matters related to labeling requirements the devices should comply with in order to be allowed for marketing and use in the country. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
FDA
The new article highlights the aspects related to biocompatibility, electrical safety, electromagnetic compatibility, and the use of wireless technologies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
FDA
The new article describes in detail the aspects related to comparison to similar medical devices already placed on the market and also outlines the scope of information to be provided with respect to the software used to operate such devices. Table of Contents The...
FDA
The article provides an overview of the applicable regulatory requirements and describes the policy the authority intends to apply. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
FDA
The new article highlights the aspects related to the scope of information to be documented in the context of pathology peer review. Table of Contents The Food and Drug Administration (FDA), the US regulatory agency in the sphere of healthcare products, has published...
