Zdrowie i gospodarka · 26/03/2014

FDA Publishes Standard Operating Procedure for Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues

The Food and Drug Administration (FDA) has released a new Standard Operating Procedure (SOP) that outlines the process for the Center for Devices and Radiological Health (CDRH) to quickly inform stakeholders about changes in expectations or new scientific information related to premarket submissions, including Investigational Device Exemptions (IDEs), Premarket Notifications (510(k)), Premarket Approvals (PMA), Humanitarian Device Exemptions (HDEs), and combination products. The SOP is now available for immediate implementation.