FDAnews Device Daily Bulletin

CDRH Requests Electronic Copies

Oct. 1, 2008
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.