FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment: Data Reporting
The final article of the cycle provides additional clarifications regarding the matters related to data reporting.
The final article of the cycle provides additional clarifications regarding the matters related to data reporting.
The article highlights the key points related to the submissions associated with novel medical devices intended to be marketed and used in the US.
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.
The document highlights the key points related to the requests for information to be submitted under the existing legal framework.
The new article provides further clarifications regarding requests for information as provided under the existing legal framework.
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