FDA
The new article highlights the aspects related to the content and format of an application for initial recognition and re-recognition as a third-party 510k review organisation.
FDA
The article addresses the aspects related to the authority’s expectations associated with the respective program.
FDA
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting.
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 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.
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