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New FDA Draft Guidance on eCopy Program for Medical Device Submissions

On Oct 18, 2012., the FDA released a new draft guidance entitled – eCopy Program for Medical Device Submissions.The intent of this guidance is to improve the efficiency of the review of an electronic version rather than relying solely on the paper version of the submission.

An electronic copy (eCopy) is defined as an exact duplicate of the paper submission, created and submitted on a CD, DVD or other electronic media format that FDA has agreed to accept accompanied by a copy of the signed cover letter and the complete paper submission.

Please note that eCopy is not considered to be en electronic submission; for eSubmisions refer to “FDA eSubmitter” and register as a submitter at the FDA Electronic Gateway.

Among other submissions, the eCopy guidance will be applicable to 510 (K)s, de novos, PMAs, IDEs and pre-submissions. Compassionate and Emergency use IDE submissions as well as an Emergency Use Authorization would be exempt. Here are some of the key highlights:

  • Regardless of the number of copies required for the submission (2-6), enclose at least 1 copy eCopy and 1 paper copy
  • Use eSubmitter–eCopies tool available at FDA website
  • Ensure that you have signed the cover letter attached to each eCopy
  • Ensure that the statement in the cover letter  meets the standard:
    • ‘the eCopy is an exact duplicate of the paper copy’; or
    • ‘the eCopy is an exact duplicate of the paper copy except (specify differences:  for raw data and statistical analysis, video files, x rays, etc.)’
  • Ensure that the structure of the submission is either:
    •  Volume-based submission – for large submissions; Vol_001 to Vol_999 recommended to have descriptive title, page X to Y in the title for easier navigation through submission; no symbols in the title, up to 250 characters; or
    • Non-volume-based submission –  if you have small a submission with single PDF file or PDF file for each item on the table of contents
  • PDF files should not exceed 50 MB
  • Avoid scanning to PDF (rather convert Word file to PDF) to ensure better quality
  • Remove attachments before submittal
  • Remove any security settings including read only and password protection
  • Statistical package should be zipped under “STATISTICAL DATA” folder; limit size to 50 MB
  • Miscellaneous files should be zipped under “MISC FILE” folder (e.g. videos, x-rays, machine readable software source code)
  • Font: Times New Roman, 12- point, black;  blue for hypertext links, avoid any light colors
  • Formatting: simple tables with black font, page with 1 inch margins, continuous pagination of the multiple PDFs in the same volume; each volume starting with page 1.
  • Bookmarks and hypertext links are recommended to allow faster locating of the information, however, they are not supported across the files.

It should be noted that any deviation from the above listed requirements may place your submission on hold as it would not be able to load up properly to the FDA systems. Therefore, I highly recommend that you read the guidance carefully and literally follow each step.

If you would like to share your opinion regarding this draft document, you can submit comments and suggestions directly to the FDA by Nov 16, 2012. The implementation date is projected to be Jan 1, 2013. Meanwhile, the FDA encourages the industry to start using eCopies immediately; see eSubmitter guide for more information.

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