The article highlights the key points associated with the substantial changes to performance studies in the context of the new regulatory framework. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission...
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...
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...
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...
The new article highlights the aspects related to the cases when the authority takes negative decisions with respect to the application submitted, the applicant decides to withdraw the application itself, as well as the key performance goals. Table of Contents The...