FDA
The article highlights the key points related to the submissions associated with novel medical devices intended to be marketed and used in the US.
FDA
The new article provides additional details pertaining to the submission template to be used by the parties interested in applying for marketing permission for medical devices utilizing innovative technologies.
FDA
The document highlights the key points related to the requests for information to be submitted under the existing legal framework.
FDA
The new article provides further clarifications regarding requests for information as provided under the existing legal framework.
FDA
The article highlights the key points associated with the use-related risk analyses to be conducted with respect to various healthcare products intended to be marketed and used in the US.
FDA
The new article provides additional clarifications with respect to the development of use-related risk analyses.
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