510k Course for FDA eSTAR – 58+ Videos, Templates, and eBook

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.”

The primary advantage of purchasing this 510k Course is that you and your team will receive invitations to new webinars whenever the FDA updates the requirements for a 510k or De Novo submission–at no additional cost. We will also be updating our existing webinars and templates as we receive feedback from FDA reviewers during the technical screening process, substantive reviews, and interactive reviews. 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, you will not receive the updated content. 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:

1. 510k Template (46MB of data as of 10/9/2023)
2. 510k and De Novo Webinars (17GB of data as of 10/9/2023)

You will need sufficient Dropbox storage space to access the content, but the content can be downloaded and saved locally.

Buy the 510k course for $1,495

510(k) Course Webinar Series

This is a 510(k) course series originally consisted of 36 webinars, an ebook, and electronic templates for your next 510(k) submission. We added a full set of templates for a 510(k) pre-submission request as well. We are updating these webinars and templates for the new FDA eSTAR templates. 23 new webinars have been recorded and we will continue to add more as the FDA makes changes. The price of this course is $1,495.

Price: $1,495.00

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 Template” folder in the 510k Course?

Obsolete 510k templates that are not intended for use with the FDA eSTAR templates have been archived permanently, and the volume/document structure is no longer used for 510k and De Novo submissions. The screen capture below shows the updated templates folder structure. There are 20 primary templates in the folder–including the two eSTAR templates, and three financial disclosure forms provided by the FDA. Most of the content that was provided in the form of templates is now incorporated into the eSTAR. If you are looking for software or cybersecurity documentation templates, those are sold separately:

• Software Validation (SYS-044)
• Cybersecurity Work Instruction (WI-007)

What are the contents of the “510k and De Novo Webinars” folder for the 510k course?

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.

Two new eSTAR templates were released on September 11, 2023:

• non-IVD eSTAR v4.3 – Update 4.3 (2023-10-12) from version 4.2: Standard recognition number can now be used to autopopulate standard information. Texts updated to clarify eCopy option is no longer permitted for 510(k)s. Reprocessed SUD directions clarified with popup message. ISO 17050-2 attachment question removed, content now collected in respective sections. Declaration of Conformity no longer requires electronic signature. Off-The-Shelf Software guidance content built into Software section help texts.
• Update 4.2 (2023-09-11) from version 4.1: Resolved bug preventing Additional Information responses from being deleted.
• Update 4.1 (2023-09-08) from version 4.0: Removed ASCA specific questions from Biocompatibility section, FDA will rely on complete reports instead. EMC section updated to include content for the IVD standard IEC 61326-2-6. Minor text changes related to ASCA. Added Attachment G option from new Biocompatibility Guidance. Inadvertent warning message no longer displays when a Package Validation type of attachment is deleted.
• Update 4.0 (2023-06-12) from version 3.0: Software section updated according to FDA Software Guidance document. Fixed bug in EMC section where if a user indicated no recognized standard was used and then chose a risk categorization above this question, content would display inadvertently. Added textbox for describing unsolicited Additional Information in Additional Information section. New 1 GB attachment size limit added to accommodate CDRH Portal restriction.
• IVD eSTAR v4.3 – Update 4.3 (2023-10-12) from version 4.2: Standard recognition number can now be used to autopopulate standard information. Texts updated to clarify eCopy option is no longer permitted for 510(k)s. Reprocessed SUD directions clarified with popup message. ISO 17050-2 attachment question removed, content now collected in respective sections. Declaration of Conformity no longer requires electronic signature. Off-The-Shelf Software guidance content built into Software section help texts.
• Update 4.2 (2023-09-11) from version 4.1: Resolved bug preventing Additional Information responses from being deleted.
• Update 4.1 (2023-09-08) from version 4.0: Dual 510(k)/CLIA Waiver by Application option was added; Assay-only submissions no longer auto-hid software, cybersecurity, EMC or wireless technology related sections; ASCA specific questions in Biocompatibility section were removed, since we will rely on complete reports instead; EMC section was updated to include content for the IVD standard IEC 61326-2-6. Minor text changes related to ASCA were added.
• Update 4.0 (2023-06-12) from version 3.0: Software section updated according to FDA Software Guidance document. Fixed bug in EMC section where if a user indicated no recognized standard was used and then chose a risk categorization above this question, content would display inadvertently. Added textbox for describing unsolicited Additional Information in Additional Information section. New 1 GB attachment size limit added to accommodate CDRH Portal restriction.
• PreSTAR v0.2 (beta version) – Update 0.2 (2023-08-14) from version 0.1: Addition of PCCP submission topic category. Minor text changes.
• Updated 0.1 (2023-06-06): Initial beta release. 

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 webinars 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.

1. How to prepare your 510k in 100 days – only available through our 510k Course
2. Predicate Selection Webinar – $64.50
3. How To Combine a 510k Submission with CE Marking Technical Files –  $64.50
4. 510k Project Management Best Practices – Free
5. 510k Project Management – Updated for 2021 – Free
6. FDA Pre-Sub Meetings –  $129
7. 510k Hardware & Software Documentation Webinar –  $129
8. 510k Submissions: Substantial Equivalence – $129
9. Vol 15 – Biocompatibility – $79
10. Vol 5 – 510(k) Summary – $79
11. Vol 19 & 20 – Animal & Clinical Studies – $79
12. Redacted FOIA 510k Webinar – $79
13. Sterilization Shelf Life Webinar – $49
14. How to Complete a 510k Cover Letter Webinar – $29
15. Labeling & UDI 510k Requirements Webinar – $49
16. Device Description Webinar – $29
17. De Novo Application –  $49
18. Small Business Qualification Fee for 510(k) Submission – $19
19. 510k Submission Section 4: Indications for Use – $64.50
20. How to complete Section 6, 7 and 8 of a 510(k) Submission – Free if you submit a question
21. FDA eCopy Print & Ship Webinar – Free if you submit a question
22. 510k FAQs Webinar – Free if you submit a question
23. 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.