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.
FDA
The new article elaborates further on the requirements to be fulfilled by the entities involved in the activity considered remanufacturing based on considerations described in the previous article.
