Checklist

Article explains how we prepare your eCopy using a checklist to ensure that the hardcopy and the eCopy match, and your eCopy will be successfully uploaded.

FDA eCopy Checklist

Fda_ecopy_checklist_161103

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Formatting Checklist
checklist

We assume that all pages will be printed in black and white with grey scale for printing of photos and graphs. If you want color you must specify which pages, documents or sections of the submission should be printed in color. You must include color printing instructions as a separate, clearly labeled document in the Dropbox folder.

We only use 20# paper to ensure that you know exactly how many pages will fit in a binder and when you might need to split your submission into two binders. Here is the maximum capacity of each size binder:

We insert dividers to separate volumes or sections of your submission if you only have one volume. This is suggested by the FDA, but not required. A typical 510k submission will have 20 dividers.

All submissions are printed directly from Adobe Acrobat DC and each page is automatically 3-hole punched by our high-speed printer.

FDA eCopy Checklist

Fda_ecopy_checklist_161103

Subscribe to download our checklist.

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