This is a webinar 510k course series consisting of 36 webinars, an ebook, and electronic templates for your next 510k submission.
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, then you will need to manually email us to request 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 templates
- 510k webinars
The templates folder includes the following content:
- 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
- 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
Buy the 510(k) course series for $995
This is a 510(k) course series consisting of 36 webinars, an ebook, and electronic templates for your next 510(k) submission. We recently added a full set of templates for a 510(k) pre-submission request as well. We will also be updating these webinars and templates for the new FDA eSTAR templates between April and August of 2022 (use the discount code “Twenty” to get $995 price).
Without knowing what stage of design 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 section of the video. Many start-up companies try to begin the 510k process without a design plan. Their intention is 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 for this is that it will help you create a realistic timeline for the overall project. The second most important reason for starting with a design planning is that it will force you to schedule the testing that is 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 that you use to plan your 510k project.
The 510k 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. I typically proceed with the following order of preparing a submission:
- Regulatory pathway, predicate selection, and testing plan
- Indications for use (FDA form 3881) – Section 4 (already drafted in pre-sub)
- Table of contents – Section 2 (this remains a work in progress until the day of submission)
- Cover sheet and cover letters – Section 3
- Truthful and accuracy – Section 6
- Class 3 summary – Section 7 (not required for an eSTAR)
- Device description – Section 10 (already drafted during pre-sub)
- Draft labeling – Section 13
- Testing sections as the reports are completed – 14, 15, 16, 17, 18, 19, 20
- Declaration of Conformity – Section 9
- SE Comparison – Section 12
- 510k Summary – Section 5
- Executive Summary – Section 11
- User Fee Coversheet (FDA Form 3601) – Section 1
The following webinars are recorded and available for immediate download from our 510k course dropbox folder (individual pricing shown below). As we update each recording, we will move the newest webinar to the top of the list, and we will update the price of the webinar to $64.50 for consistency. 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
- 510k Predicate Selection Webinar – $64.50 (recorded March 28, 2022)
- 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 – $129
- 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
In addition, anyone that purchases the 510k course will also receive access to our 510k templates electronically in the same dropbox folder. I recently added a full set of templates for a 510k pre-submission request as well.
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.