At the beginning of 2015 I wrote a blog about 510(k) project management (http://medicaldeviceacademy.com/510k-project-management-an-inside-look-at-our-process/) and I recorded a webinar on the topic (http://medicaldeviceacademy.com/510k-project-management-webinar/).

Since that time, the FDA release several new guidance documents related to 510(k) submissions (see list at the end).
Despite all the perceived changes to the FDAs 510(k) process, the format and content requirements have not changed much. The most significant change to the 510k process was the introduction of the Refusal to Accept Policy in 2012. The RTA process simply provides a checklist for reviewers to screen submissions to ensure the submission is complete and follows the required format.

There are 20 sections to a 510k submission. The FDAs eCopy guidance offers to options for formatting of the 510(k) submission: 1) 20 volumes and documents within each volume, 2) one volume and multiple documents within that volume. Some submissions are even organized into a single PDF, however, over time I have found that it is much easier to make revisions and coordinate the work of multiple people at different locations by organizing the 510(k) submission into 20 volumes and documents within each volume. Therefore, this is how my table of contents template is organized.

Earlier today I released a new version of my table of contents template that includes biocompatibility testing that is typically required and software documentation that is typically required. I added these documents, because these are often the last documents to be completed for the submission and I want to make sure everyone on the team is aware that these documents are needed at the very beginning of a new 510(k) project.

In order to communicate the status of documents required for a submission, I no longer use multiple tracking tools. Now I only use the Table of Contents document and I color code the status of each document directly in the table of contents. Here are the new color codings that I use for document status:

green = ready to PDF for eCopy submission
blue = requires client’s signature
yellow = document requires revision and/or reformatting of content
red = document is not started

If you were already subscribed to my email list for the 510(k) table of contents template, you should have received an updated template this morning. If you want to subscribe, here’s the link for downloading your own updated template:

http://medicaldeviceacademy.com/510k-project-management-an-inside-look-at-our-process/ – The form is at the end of the article.
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If you would like to learn more about how to manage 510(k) projects, and you want to avoid the mistakes others have made, sign up for next week’s webinar:

http://medicaldeviceacademy.com/510k-project-management-lessons-learned/

List of Guidance Documents:
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm470201.pdf – 7/11/16, EMC Data
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm348890.pdf – 6/16/2016, Applying ISO 10993-1
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm259760.pdf – 2/3/16, Human Factors
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm313794.pdf – 12/3/15, eCopy
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm458634.pdf – 9/24/15, GUIDID Database
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm315014.pdf – 8/4/15, RTA Policy

source: https://www.linkedin.com/groups/2070960/2070960-6165908772142272513