As part of the FDA Reauthorization Act (FDARA) and the Medical Device User Fee Amendments (MDUFA IV) of 2017, the U.S. Food and Drug Administration (FDA) committed to developing electronic submission templates. The intent of these templates is to provide guided submission preparation tools, improve submission consistency, and enhance efficiency in the review process. Since the commitment was announced, the FDA has issued guidance documents on electronic submissions for medical devices, developed the electronic Submission Template and Resource (eSTAR), and launched the voluntary eSTAR Program.
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