The 510k course includes 22 new eSTAR webinars, 36+ historical webinars, electronic templates for your next 510k submission, and the eBook “How to Prepare a 510(k) in 100 days.”
When you purchase our 510k course, you will receive an automated email asking you to confirm your desire to join an email subscription. We deliver all of the updated content through AWeber email subscriptions. If you do not subscribe, email us to request manual updates. The first email you will receive is to thank you for your purchase and for subscribing to email updates. The email includes a link to two Dropbox folders:
- 510k and De Novo Webinars
- 510k template
Buy the 510k course for $1,495
Note: If you purchased our new FDA PreSTAR tutorial ($299), you will receive a credit for that prior purchase. Just email Becca Taylor asking her to email you an invoice for the lower amount, or she can issue a partial refund.
What are the contents of the “510k and De Novo Webinars” folder?
The screen capture below shows the organization of the 510k and De Novo Webinars folder for the new webinars we created for the eSTAR. The 36+ historical webinars we created for 510k submissions are also in the folder. Many of these webinars are 100% new content, such as “9 – eSTAR Reprocessing” which focuses on the 510k submission requirements for reprocessed devices single-use devices, and reusable devices that require cleaning validation.
What are the template folder contents for the 510k course?
Anyone that purchases the 510k course will also receive access to our 510k templates electronically in a Dropbox folder.
- a PDF version of the book we created on 510k submissions
- empty folders we use to organize and build a pre-submission and/or 510k
- a subfolder with our pre-submission templates
- all of our current 510k templates, including the two eSTAR templates
- a subfolder with the most current eSTAR templates from the FDA, our 510k planning table of contents, and the cover letter template for an eSTAR submission
Note: We use empty folders as a tool in our workflow. We keep incomplete templates outside the folders. Once we fill in the templates, we move the completed file to the folder and update the table of contents. On October 1, 2023, we will update the templates folder with a new structure to match the new eSTAR format. The empty folders are used to organize testing reports as reports become available. An updated table of contents will be provided for the eSTAR as well. The table of contents is our planning tool–not a document included in the eSTAR.
Two new eSTAR templates were released on March 30, 2023:
- non-IVD eSTAR v3.0 – Update 3.0 (2023-03-29) from version 2.2: Updated FDA Accessories section to simplify data collection and include policies on kits and components. Question regarding safe use of magnets was added to Labeling. Resolved two bugs in Sterility introduced when PMA content added in Version 2.2: Sterility information will now be displayed after using the Import function, and the Sterility indicator will now change properly when switching between FDA PMA and other FDA submission types. PCCP checkbox added to Device Description. Animal Testing guidance information added. Combination product questions updated. Cybersecurity help text updated per Section 524B of the FD&C Act.
- Version 2.2 of the non-IVD template was released on January 10, 2023.
- IVD eSTAR v3.0 – Update 3.0 (2023-03-30) from version 2.0: EMC section updated to new EMC Guidance content.
- Update 2.0 (2023-03-29) from version 1.5: Updated FDA Accessories section to simplify data collection and include policies on kits and components. Human Factors/Usability information added to the help text for the Analytical Performance Supportive Data question. Resolved two bugs in Sterility introduced when PMA content added in Version 2.2: Sterility information will now be displayed after using the Import function, and the Sterility indicator will now change properly when switching between FDA PMA and other FDA submission types. PCCP checkbox added to Device Description. Animal testing guidance information added. Combination product questions updated. Cybersecurity help text updated per Section 524B of the FD&C Act.
- Version 1.5 of the IVD template was released on January 10, 2023.
Without knowing what design stage you are in, we can’t tell you where to start watching our 510k course webinars. However, the following YouTube video might help you figure out where you are in the design process. The video has timestamps that allow you to advance and rewatch any video section. Many start-up companies try to begin the 510k process without a design plan. They intend to create the design plan and design history file (DHF) retrospectively after they submit their 510k submission. However, this is a mistake. You should always start your 510k project with a design plan. The primary reason is that it will help you create a realistic timeline for the overall project. The second most important reason for starting with design planning is that it will force you to schedule the testing required for verification and validation (V&V) testing–as well as any pre-requisites that must be completed before you begin V&V testing. We have another form that allows you to download our design plan template and our 510k table of contents. These two documents are the primary planning tools we recommend you use to plan your 510k project.
The 510k and De Novo Webinars folder includes all of our current and past webinars on 510k submissions. It also includes an Excel spreadsheet with a list of the webinars. That list has a column identifying the applicable section of a 510k covered in the webinar. Therefore, you can watch the videos based on the section you are working on.
The following webinars are historical webinar available for immediate download from our 510k and De Novo Webinars Dropbox folder (individual pricing is shown below). Links to free webinars can be found in the webinar list you can download, and we will be updating those webinars last. All the free webinars will be posted on our YouTube channel.
- How to prepare your 510k in 100 days – only available through our 510k Course
- Predicate Selection Webinar – $64.50 (updated on September 20, 2023)
- How To Combine a 510k Submission with CE Marking Technical Files – $64.50 (recorded on April 4, 2022)
- 510k Project Management Best Practices – Free (recorded again on May 30, 2022)
- 510k Project Management – Updated for 2021 – Free (recorded on May 21, 2021)
- FDA Pre-Sub Meetings – $129 (scheduled for an update in June 2022)
- 510k Hardware & Software Documentation Webinar – $129 (scheduled for an update in June 2022)
- 510k Submissions: Substantial Equivalence – $129 (scheduled for an update in June 2022)
- Vol 15 – Biocompatibility – $79
- Vol 5 – 510(k) Summary – $79
- Vol 19 & 20 – Animal & Clinical Studies – $79
- Vol 11 – Executive Summary & RTA Checklist – $79
- Redacted FOIA 510k Webinar – $79
- FDA Declaration of Conformity (Form 3654) Webinar – Obsolete, no longer required by FDA.
- Sterilization Shelf Life Webinar – $49
- How to Complete a 510k Cover Letter Webinar – $29
- Labeling & UDI 510k Requirements Webinar – $49
- Device Description Webinar – $29
- De Novo Application – $49
- Small Business Qualification Fee for 510(k) Submission – $19 (Scheduled for update on June 5, 2022)
- 510k Submission Section 4: Indications for Use – $64.50 (see our new YouTube Video recorded 12/1/2022)
- How to complete Section 6, 7 and 8 of a 510(k) Submission – Free if you submit a question
- FDA eCopy Print & Ship Webinar – Free if you submit a question
- 510k FAQs Webinar – Free if you submit a question
- 510k Software Documentation Webinar – Free Download
To give you an idea of what we have included in our 510k course, below is a YouTube video that was recorded with Joe Hage in October 2018 explaining how to prepare a 510k submission.