Friday, January 4, 2013

FDA Finalizes 510(k), PMA, eCopy Guidances

FDA Finalizes 510(k), PMA, eCopy Guidances-thegraysheet: 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.