This webinar explains the process for a De Novo application to the FDA for medical devices that are not eligible for 510k submissions.
This webinar has been updated for FY 2019 on January 4, 2019, to reflect changes in the De Novo application process since January 2016 when the original webinar was recorded. A download link for this De Novo application webinar will be sent by email to you if you fill out the form to the right. 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.
Do you need help submitting your De Novo Classification Request?
If you need help with the validation of your FDA eCopy, we offer an FDA eCopy print and ship service for $99/eCopy. We will also be updating this webinar in 2022 to explain how to use the new FDA eSTAR template for De Novo Classification Requests.
De Novo Application Webinar Content
- Updates for FY 2019
- Our firms 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
- De Novo Table of Contents Template
- De Novo Cover letter Template
Webinar is $49.00– (INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):
This updated webinar for FY 2019 explains the process for a De Novo application to the FDA for medical devices that are not eligible for 510k submissions.
10- Question Exam and Training Certificate available for $49.00:
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
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.
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. Robert was a senior manager at several medical device companies—including 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. Robert’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 802.281.4381 or by email. You can also follow him on Google+, LinkedIn, or Twitter.