{"id":577,"date":"2015-12-07T19:51:02","date_gmt":"2015-12-07T19:51:02","guid":{"rendered":"https:\/\/awrightpath.net\/?p=577"},"modified":"2019-06-05T19:52:21","modified_gmt":"2019-06-05T19:52:21","slug":"updates-to-fdas-ecopy-guidance","status":"publish","type":"post","link":"https:\/\/awrightpath.net\/updates-to-fdas-ecopy-guidance\/","title":{"rendered":"Updates to FDA?s eCopy Guidance"},"content":{"rendered":"\n

On December 3, 2015, the FDA?s Center for Devices and Radiological Health (CDRH) issued a revised version of the guidance document, ?eCopy Program for Medical Device Submissions<\/a>,? that clarifies certain aspects of the prior guidance. This guidance replaces the prior version of this guidance issued on October 10, 2013.<\/p>\n\n\n\n

The purpose of this guidance is to explain the electronic (eCopy) program for medical device submissions and to provide information on the processing and technical standards for eCopies based on FDA?s experience to date with the program.<\/p>\n\n\n\n

Clarification and improvements to the eCopy Program have been identified through review of the program and surveys to Industry and FDA Staff. As part of the implementation of the Booz Allen Hamilton (BAH) independent assessment of the device review process<\/a>, the FDA has revised the eCopy guidance to address the recommendation to ?provide increased clarity to applicants to emphasize the rationale for applying navigation support and provide greater specificity to existing application submission instructions to ease FDA staff navigation of submission reviews.?<\/p>\n\n\n\n

Below is a summary of the types of changes incorporated into the revised guidance document:<\/p>\n\n\n\n

Key Changes<\/strong><\/p>\n\n\n\n