This article explains our 510k project Using the new FDA eSTAR template also requires a new process for eSTAR project management to prepare your 510k and De Novo submissions.
Outline of ten (10) major changes resulting from the new FDA eSTAR template
As of October 1, 2023, all 510k and De Novo submissions to the FDA now require using the new FDA eSTAR template and the template must be uploaded to the FDA Customer Collaboration Portal (CCP). Yesterday the FDA published an updated guidance explaining the 510k electronic submission requirements, but there are ten (10) major changes to Medical Device Academy’s submission process resulting from the new eSTAR templates:
- We no longer need a table of contents.
- We no longer use the volume and document structure.
- We are no longer required to conform to sectioning or pagination of the entire submission.
- We no longer worry about the RTA screening or checklist (it doesn’t exist).
- We no longer bother creating an executive summary (it’s optional).
- We no longer have a section for Class 3 devices, because there are no Class 3 510(k) devices anymore.
- We no longer use FDA Form 3514, because that content is now incorporated into the eSTAR.
- We no longer create a Declaration of Conformity, because the eSTAR creates one automatically.
- We no longer recommend creating a 510(k) Summary, because the eSTAR creates one automatically
- We no longer use FedEx, because we can upload to FDA CCP electronically instead.
What is different in the 510k requirements?
Despite all the perceived changes to the FDA’s pre-market notification process (i.e., the 510k process), the format and content requirements have not changed much. The most significant change to the 510k process recently was the requirement to include cybersecurity testing.
Outline of eSTAR Project Management
There were 20 sections in a 510k submission. Medical Device Academy’s consulting team created a template for the documents to be included in each section. In the new eSTAR template, there are no section numbers to reference. To keep things clear, we recommend using one or two words at the beginning of each file name to define the section it belongs in. The words should match up with the bookmarks used by the FDA. However, you should be careful not to make the file names too long. Below is a list of all of the sections:
- Administrative Information;
- Device Description;
- Predicates and Substantial Equivalence;
- Benefits, Risks, and Mitigation Measures;
- Reprocessing, Sterility, and Shelf-life;
- Software/Firmware and Cybersecurity/Interoperability
- EMC, Wireless, Electrical, Mechanical, and Thermal Safety;
- Performance Testing;
- Quality Management; and
- Administrative Documentation.
The Benefit, Risks, and Mitigation Measures Section is only applicable to De Novo Classification Requests. The Quality Management Section includes subsections for Quality Management System Information, Facility Information, Post-Market Studies, and References. However. Only the References subsection will be visible in most submissions because the other three subsections are part of the Health Canada eSTAR pilot. Other sections and subsections will be abbreviated or hidden depending on the dropdown menu selections you select in the eSTAR. For example, if your device does not have wireless functionality or a removable storage drive, then the cybersecurity section will remain hidden.
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.