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FDA UPDATE Aug 29, 2006

29^th August: Electronic Copies for Pre-Market Submissions

FDA is encouraging sponsors of premarket medical device 510(k) submissions to include a copy of their submission in electronic form along with the required paper copies.

It is not compulsory that you submit your 510(k) applications electronically.  Any one can choose to submit via the traditional paper route.  The electronic process (using eSubmitter) is a pilot project that FDA is promoting.

An electronic copy is an exact duplicate of a paper submission, created and submitted on a CD or DVD and should be sent in an Acrobat Portable Document Format (PDF). All the documents that require signature should be send on paper along with electronic copy.

To make sure electronic copy is compliant with FDA requirements, minimum instructions has to be followed and are as follows:

1. Naming of folders and files
2. Bookmarks
3. Optical Character Recognition

Detailed information can be found at http://www.fda.gov/cdrh/elecsub.html#Naming & http://www.fda.gov/cdrh/elecsub.html#Bookmarks

For the present, an appropriately bookmarked, OCR electronic copy will serve as one of the required number of copies for the various premarket submission types if it meets the requirements described by FDA for electronic copy.

FDA has guidance to convert word file into PDF and also information on paper margin required. You can locate guidance at http://www.fda.gov/cdrh/elecsub.html

If you have comments regarding this update, please email us at info@mdiconsultants.com

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