Article summarizes format content requirements for a 510(k) submission to the US FDA for medical devices, including volume and document organization.
The FDA requires that your 510(k) submission is organized into 20 sections as described in the adjacent table. You must provide both a hardcopy of the submission and an electronic copy (i.e., eCopy) that is identical to the hardcopy submission. The FDA eCopy guidance document was issued in December 3, 2015. The eCopy guidance gives you the option of organizing the 20 sections into 20 volumes with multiple documents in each volume or to submit a single volume with all the documents. The word “volume” refers to electronic folders rather than binders. Submissions that are less than 600 pages require a single 3-ring binder, while larger submission will require multiple binders. My table of contents template assumes that your submission will be small enough to fit in one binder, but if your submission is larger than 600 pages you should split the table into two tables and add a header that identifies each binder (i.e., Binder #1, Binder #2, etc.).
The FDA requires that the hardcopy be printed on 8.5”x11” sheets of paper and the left-hand margin of each page should be 3-hole punched. I’m not 100% sure if the FDA discards the thousands of 3-ring binders they receive each year, but the FDA website claims that the document mail center transfers every submission into FDA-issued 3-ring binders. Therefore, for larger submissions you should only use 20# paper and you should split your submission into two or more binders by ending one binder at the end of a section so that each binder has approximately the same number of pages.
Format Content: Single Volume or Multiple Volumes?
There is no right or wrong choice regarding volumes—if your eCopy uploads. The answer to this question is a personal preference. The FDA recommends that multiple volumes be used for larger submissions, but using the same process for every 510(k) submission makes submission teams more efficient. Therefore, I always use multiple volumes for every submission. Submissions are organized into 21 volumes to match the 20 sections of a 510(k) submission and the 21st volume is reserved for an RTA Checklist that I complete to assist the reviewer in completing their own RTA checklist. The FDA recommends using the 21st volume for miscellaneous appendices, but the volume structure of the submission makes it easy to insert miscellaneous content directly into the applicable sections by adding documents after the initial section summary document.
Format Content: Overall Numbering or Numbering within Sections?
Again, this is a personal preference. However, there are always last minute changes to documents. Therefore, whichever numbering system you use should minimize the need for last-minute renumbering of the entire submission. This is especially painful when you number the overall submission and then you add a page to the middle of the submission at Staples when you trying to ship out your submission that day. Are you going to reprint 400 pages or renumber 400 pages by hand? Therefore, I prefer to number within sections.
Format Content: Using Your Table of Contents for Project Management
When I was less experienced I used project management software and action item lists to manage submission projects. Experience has taught me to simplify. Now I only use an action item list to track progress of individual tasks. To track the overall submission, I now use the table of contents as my project management “report.” If you color-code the rows of your table of contents you can communicate the status of each document in the submission. At the beginning of the project, all the rows indicate documents are not yet started—signified by the color red. Once I being a document, I change the color to yellow. Finally, when the document is completed I change the color of the row to green. There are also three documents that require the signature of the official correspondent with the FDA:
- 510(k) Cover Letter
- Certification Regarding Confidentiality
- Truthful and Accuracy Statement
Once these three documents are completed, they still need a signature that should only be applied just before we prepare the eCopy. Therefore, I signify the status of documents waiting for signatures with blue rows. A couple of people struggle with reformatting row colors, but every single person on your team will understand that they want the table of contents to gradually change from red, to yellow and finally to 100% green.
How to Prepare Your 510(k) in 100 Days
This article is an excerpt from the fifth Chapter of “How to Prepare Your 510(k) in 100 Days.” Final edits will be completed this month and the final printed book will be shipping in February. If you want to pre-order a copy, please click on the hyperlinked title.
FDA eCopy Checklist
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