FDA Outlines Mandated eCopy Submission Program In Draft Guidance
This article was originally published in The Gray Sheet
The agency issued a draft guidance listing the requirements for its eCopy submission program for medical devices. An eCopy will be mandatory for all device firms after the draft is finalized.
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FDA spells out its acceptance policies for 510(k) and PMA submissions, as well as guidelines for submitting electronic copies of submissions. The guidances all aim to make the device review process more efficient and speedy.
News on FDA workforce troubles, feedback on CDRH’s eCopy policy and more.
For now, CDRH remains in a transition phase on its new refuse-to-accept policies for PMA and 510(k) submissions and its mandate for electronic copies of pre-market submissions, each of which have been addressed in recent guidance documents.