FDAnews Device Daily Bulletin

CDRH Requests Electronic Copies

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When submitting premarket medical device submissions to CDRH, manufacturers should include an electronic copy along with their paper copies. The electronic copy should be created as a PDF and submitted on a CD or DVD. Clinical data files submitted in support of the review may be in SAS, XPORT, XML, SGML and Molfile formats, CDRH says in a new question-and-answer document on submitting electronic copies. Any submission type [510(k), IDE, PMA, 513(g), Pre-IDE, HDE, PDP, Emergency Use Authorization and subsequent amendments or supplements] can be submitted as an electronic copy.