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.
FDA
The new article provides a general overview of several examples demonstrating the way the regulatory approach described in previous articles should be applied.
CBRN
The article provides a brief overview of a special regulatory framework introduced for certain in vitro diagnostic medical devices.
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