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.
De Novo Application Webinar Content
- De Novo Application Guidance Document
- De Novo With or Without Preceding 510k
- De Novo Pre-Sub Meetings and Questions to Ask
- Which sections of application are unique to a De Novo?
What you will receive:
- Recording of live webinar
- Native PowerPoint Slide Deck
- De Novo Project Planning Tool
- De Novo Table of Contents Template
- De Novo Cover letter Template
Webinar is $49.00– (INCLUDES NATIVE SLIDE POWERPOINT PRESENTATION FILES):
This webinar 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
Robert Packard is a regulatory consultant with ~25 years 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 certification. From 2009-2012, 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 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.