“510k Project Management-An Inside Look at Our Process” explains how the 510k Table of Contents is used for client submissions. A free download is provided.
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 (http://bit.ly/FDA-RTA-Policy) 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” (http://bit.ly/510k-Content). To ensure that you don’t deviate from this required format, use a standardized template for the Table of Contents.
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, 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 a 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 (http://bit.ly/FDA-eCopy). Periodic updates are provided to the client via conference calls. Still, the client can view progress on the overall 510k submission project almost real-time by reviewing the 510k Table of Contents in spreadsheet form.
Coordinating Our Team
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), biocompatiblity (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 will also update our Table of Contents and send it to you if there are changes to the 510k requirements after the FDA has completed its retrospective review of the 2005 guidance document later this year (http://bit.ly/FY2015-Proposed-FDA-guidance).
Additional 510k Training
The new 510k book, “How to Prepare Your 510k in 100 Days,” ships on Monday, February 6th, 2017. There is also an on-line 510k course series consisting of 24 webinars. Please visit my webinar page to purchase individual webinars. We also have live 510k workshops