FDA
The new article provides further clarifications related to gathering additional information.
FDA
The new article highlights the key aspects related to the way test articles should be extracted in order to ensure the accuracy and reliability of further assessment.
FDA
The new article explains in detail the way chemical analysis should be conducted in order to ensure any and all key matters are addressed properly.
FDA
The final article of the cycle provides additional clarifications regarding the matters related to data reporting.
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.
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