Our 510k Project Management Tool – An Inside Look at Our Process
This article explains our 510k project management tool, the 510k Table of Contents, and we provide a form to request a free template.
Despite all the perceived changes to the FDA’s pre-market notification process (i.e., 510k 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 (now updated for 2019) in 2012. The RTA process did not, however, change requirements for format and content. The RTA process simply provides a checklist for reviewers to screen submissions to ensure the submission is complete and follows the required format. Actual content requirements can be found in a 2005 guidance document titled, “Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s”. To ensure that you don’t deviate from this required format, use a standardized template for the Table of Contents.
Overview of our 510k project management tool
There are 20 sections to a 510k submission. For each section, Medical Device Academy’s consulting team created a template for the documents to be included in that section. Each section is assigned a volume number (i.e., 1-20), and typically there is an overview document for the section that is identified by Vol x Doc 1. We also use a consistent header and footer for every document to identify the subject device of the submission, the name of the section, and the volume/document numbers. In addition to the templates our consulting team created, several FDA forms must be used for specific sections. These forms are a mixture of MS Word® documents and PDF documents that must be edited in Adobe Acrobat®.
Table of Contents Used as our 510k Project Management Tool
When one of our consultants is starting a new 510k project, we use a spreadsheet version of the Table of Contents. This allows us to perform a gap analysis of the existing documentation available from the client. If the client owns the 510k for the predicate device, then the client may only need to update documents to reflect changes. If the client has a Technical File, then most of the information is available. Still, the consultant must revise the format and organization of the content to fit our 510k document templates. In one of the columns of the spreadsheet, the consultant performing the gap analysis makes comments about what is available and what needs to be done to complete the 510k submission.
Status of Documents
To communicate the status of documents in the gap analysis, and throughout the 510k project, the consultant will color code the sections of the table of contents:
- green = ready for submission
- blue = ready for the client’s review and approval
- yellow = document requires revision and/or reformatting of content
- red = the information does not appear to be available
Our consulting team also uses this same color coding approach when we create a Technical File or a Design Dossier for CE Marking. We will include cross-references to document and report numbers if controlled documents are available. We also add two columns to track our estimated and actual consulting time for the project. Estimated hours required to complete each section are provided, and then as the project progresses, we update the spreadsheet to include the actual time spent on each section.
We share the planning spreadsheet and the documents created for each section of the 510k submission with our clients using http://www.dropbox.com/. In each client’s Dropbox folder, we have sub-folders for the 20 sections of the 510k Table of Contents. As we finalize each document, the documents are reviewed and approved by the client. After final approval of the documents, each document is saved as a PDF–as required for eCopy submissions (updated in 2020). Periodic updates are provided to the client via conference calls. Still, the client can view progress on the overall 510k submission project in almost real-time by reviewing the 510k Table of Contents in spreadsheet form.
Team coordination using our 510k project management tool
We also use our 510k Table of Contents to help identify who is responsible for each section of a 510k submission. Not every consultant is an expert in electrical safety (section 17), biocompatibility (section 15), and pre-clinical animal studies (section 19). Most of Medical Device Academy’s consultants are specialists in a narrow discipline. Therefore, it is common for us to assign different sections to different consultants. By using the same templates and process for each submission, a team can work efficiently from 3 or 4 countries simultaneously on the same 510k submission.
Prioritizing Section Completion
Each section of the 510k submission must be completed, but the order of completing the sections is important. For example, we find that the first section to complete is in section 4–the Indications for Use. This section is essential because the Indications for Use should match the predicate device we are claiming substantial equivalence to in section 12.
Another section we like to work on very early in the project is section 13 for Proposed Labeling. The labeling includes the Instructions for Use (IFU), and the IFU must consist of a statement of the Indications for Use. The sections we prioritize last are the sections that summarize verification and validation testing that has been done. These sections are done last because we find we are almost always waiting for a test report at the end of the project. We also find that testing sometimes needs to be repeated.
Please fill in the form at the bottom of this page if you would like to receive Medical Device Academy’s template for the 510k Table of Contents. We updated our Table of Contents in 2021 again and you can receive a copy via email if you complete the AWeber form below and confirm your desire to receive email updates.
Additional 510k Training
The new 510k book, “How to Prepare Your 510k in 100 Days,” was completed in 2017 but the book is only available as part of our on-line 510k course series consisting of 24+ webinars. Please visit the webinar page to purchase individual webinars.
Posted in: 510(k)Leave a Comment (20) ↓
Thanks for sharing this. Good information-Well thought out process.
Thank you for the positive feedback David.
Thanks for adding this – as a PMP, I couldn’t agree more. There isn’t any need for a GANNT chart or anything complicated.
I have been using a modified but almost identical technique that you describe above. The TOC is the framework and color coding with a legend does the job for me!
I also keep a separate file for “Consistent Terms” – i.e. IFU, and any other relevant data that will be populated in various sections is in one place.
I hope your up upcoming workshop it a great success.
Thank you for the positive feedback Valerie. I always find it interesting that regulatory consultants come up with similar solutions independently around the world.
Thanks Rob – I just noticed that I spelled GANTT chart wrong – so I guess that proves I am not a fan!
From my perspective, what you have done is point out possibly the key criteria for success from my limited time in this industry – you have to be organized. I also agree with your comments on the long lead times typically being any type of testing and labeling.
So some of my experience is lessons learned and some (or most) is transferrable skills. I am glad that I found this industry and the opportunities that are available.
I hope we can continue to share experiences as going forward.
You are not the only person that misspells Gantt chart and not everyone is a fan of them. Personally I like spreadsheets, but there are some other tools that I recommend trying: ASANA and Basecamp.
I look forward to hearing more from you.
Thanks Rob. I am not familiar with either one of them. I will check them out.
Thank you for the template.
Would love a copy of the described template.
Thank you for your interest Bryan. We are constantly updating our templates for 510(k) submissions based upon weekly feedback from reviewers on multiple submissions. We also create new templates for specific sections. For example, we had a template for the device description, but it didn’t meet the requirements for IVD products. Therefore, we created a new template specifically for those submissions. I will email you the current template for our Table of Contents, but if you want all the templates, including the pre-submission templates, then you will need to purchase our 24-webinar series or register for one of our 2-day 510(k) workshops. The next workshop is scheduled for March 20-21 in Las Vegas. Here’s the link for the workshop: https://medicaldeviceacademy.com/las-vegas-510k-workshop.
Thank you for the information on your blog. Yes I would like to receive the Medical Device Academy’s template for the 510k Table of Contents.
Check your inbox.
Would love a copy of the template
Just ask and you shall receive. Check your in-box. Sorry you had to wait so long. I’m very behind on reviewing comments.
I would like to receive the Template format for 510k Submission.Can you please send me?
Check your email for our template of the 510(k) table of contents. However, if you are interested in our templates for the entire 510(k) and pre-submission, these can be purchased on the following webpage: https://medicaldeviceacademy.com/510k-course/.
Hi Rob and team,
Thank you for this very helpful information. I would like to receive the free download of the template please.
I will send you an email separately, but these downloads should be received as an email subsubscription request via AWeber.
This article was updated and the AWeber form was updated so you can properly request a template via AWeber. Thank you for identifying the broken link to the AWeber form.