In this De Novo Application Webinar you will learn about the latest FDA guidance and how to use the latest FDA eSTAR template.
De Novo Application Webinar ($79)
This webinar was hosted live in 2019 and again in 2022. We are updating the De Novo Application webinar to include guidance and requirements for 2024. The webinar explains the process for a De Novo application to the FDA using the latest version of the FDA eSTAR.
10- Question Exam and Training Certificate available for $49.00:
Please note: These products will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
If you have a device that falls into one of the following categories, your device is generally eligible for the De Novo process:
- lack of an identifiable predicate device,
- new intended use, or
- different technological characteristics that raise different questions of safety and effectiveness.
Devices that are not substantially equivalent solely based upon a lack of performance data are not eligible for the De Novo process.
When is the De Novo Application webinar?
This webinar will be live on Thursday, August 1, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish. If you need help preparing your FDA eSTAR submission, we offer a standard fee for De Novo submissions or we can help you on an hourly basis.
De Novo Application Webinar Content
- Updates for FY 2024
- Our firm’s experience with De Novo applications
- De Novo Application Guidance Document
- De Novo With or Without Preceding 510k
- De Novo Pre-Sub Meetings and Questions to Ask
- Which sections of the application are unique to a De Novo?
What you will receive in the De Novo application webinar:
- Recording of live webinar
- Native PowerPoint Slide Deck
If you would like to upgrade your purchase to our entire 510(k) Course, which includes templates and webinars for pre-submissions, 510(k) submissions, and De Novo applications, please contact Lindsey Walker and she will provide you with a quote that includes a credit for your purchase of the De Novo webinar.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.