FDA Enforcement Policy for PMA and HDE Supplements: Details
The present article describes in detail the policy followed by the authority concerning specific supplements.
The present article describes in detail the policy followed by the authority concerning specific supplements.
The new article highlights the key points related to the requests, the way they should be submitted, as well as the relevant processes and procedures associated thereto.
The article outlines the key points associated with the enforcement policy related to certain supplements.
The new article addresses the matters related to the labelling requirements to be fulfilled when placing clinical electronic thermometers on the market.
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.
The article provides an overview of the existing framework for electronic thermometers.