The price for FDA eCopy services depends upon two factors: 1) how many pages is your submission, and 2) whether you need color printing.
Price factors #1 for an FDA eCopy: page count
The price for preparing an FDA eCopy depends upon the number of pages, because many submissions are shorter in length. For example, if you need to revise the 510k summary your hardcopy may be less than 10 pages. The price of printing and shipping 10 pages is less than 1,000 pages, but there is a minimum charge for FedEx express shipments. All of our flash drives cost the same regardless of how much data storage you need, and there is very little difference between the cost of 3-ring binders.
Price factor #2 for an FDA eCopy: color
There is no requirement for color printing, and FDA will not care if your hardcopy is in color or black and white (B&W) print. However, some graphs and photos communicate more information if they are printed in color. We assume that all pages will be printed in B&W 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.
Standard Price for an FDA eCopy
We am offering this service for a rate of $250.00 + $0.15/page for B&W (+$0.30/page for color). This rate includes shipping, binder, box and the flash drive. For example, a typical 1,000 page B&W submission would cost $400. Our formating checklist also shows how we document the price determination for your FDA eCopy.
Standard Price for an FDA eCopy of Pre-Sub or Meeting Minutes
Pre-sub meeting requests and meeting minutes are generally very short and often consist of a single document or a single volume with 10-15 documents. Typically these submissions are less than 100 pages and we can ship in a small FedEx box or a FedEx envelope. Therefore, we only charge a $150/each for a pre-sub or meeting minutes.
To place an order and pay on-line with a credit card, please visit the following webpage: http://medicaldeviceacademy.com/fda-ecopy-webinar/.
FDA eCopy Checklist
Subscribe to download our checklist.