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,” that clarifies certain aspects of the prior guidance. This guidance replaces the prior version of this guidance issued on October 10, 2013.
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.
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, 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.”
Below is a summary of the types of changes incorporated into the revised guidance document:
- Explains the importance of bookmarks and hyperlinks to improve navigation through PDF documents. Provides simple instructions on creating bookmarks and hyperlinks in PDF documents, including links to other PDF files in the submission.
- Explains the importance of creating a PDF file from the source document for the automatic creation of searchable text in the PDF.
- Encourages the use of the eCopy Validation Module (downloadable zip file) to determine if an eCopy meets the required technical standards.
- Highlights suggestions on submission size, the eSubmitter-eCopies Tool, the eCopy Validation Module, and mailing in “Tips to Sponsors” text boxes.
The eCopy guidance revisions do not represent significant changes to the prior version of the guidance, but rather are targeted to improve the eCopy Program by clarifying the importance of navigation support and highlighting existing tools for the creation of an eCopy.