FDA
The article outlines the key points of the approach to be used in order to improve participation in clinical studies conducted in the US.
FDA
The article describes in brief the key points related to the regulatory framework for laboratory-developed tests.
FDA
The new article describes in detail the applicability scope of the new regulatory policy for laboratory-developed tests.
Canada
The article describes the approach to be applied to innovative medical devices utilizing machine-learning technology.
FDA
The article provides a brief overview of the regulatory approach to be applied with respect to certain tests intended to be used in the context of an emergency.
FDA
The new article describes in detail special considerations related to remanufacturing medical devices and the determination of the legal status of such activities.
