FDA
The article outlines the key points associated with the enforcement policy related to certain supplements.
FDA
The new article addresses the matters related to the labelling requirements to be fulfilled when placing clinical electronic thermometers on the market.
FDA
The new article highlights the key points related to the specific aspects of selecting proper predicates to demonstrate compliance with the applicable regulatory requirements for the medical device in question is subject to.
FDA
The article provides an overview of the existing framework for electronic thermometers.
FDA
The new article describes in detail the enforcement policy introduced by the authority and also highlights the key points to be considered in order to comply with it.
FDA
The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that are cleared based on well-established methods, and also for the products that meet or exceed the expectations.
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