Classification Rationale Webinar

In our classification rationale webinar, you will learn how to write a classification rationale for De Novo applications.

Classification Rationale Webinar ($49)

This webinar was specifically created for medical device companies that are preparing a De Novo application using the latest version of the FDA eSTAR. On page 7 of the FDA eSTAR you will need to select Class 1 or Class 2 (almost always Class 2 will be required). Then you will have to write a justification for the classification you chose. Class 1 devices only require General Controls (i.e., labeling), while Class 2 devices require Special Controls (e.g., biocompatibility testing, sterilization validation, software validation). In this webinar we will also recommend a simple method for writing a regulation name and identifying the most likely regulation number for your De Novo application.

Classification Rationale Webinar

This webinar was specifically created for medical device companies that are preparing a De Novo application using the latest version of the FDA eSTAR. On page 7 of the FDA eSTAR you will need to select Class 1 or Class 2 (almost always Class 2 will be required). Then you will have to write a justification for the classification you chose. Class 1 devices only require General Controls (i.e., labeling), while Class 2 devices require Special Controls (e.g., biocompatibility testing, sterilization validation, software validation). In this webinar we will also recommend a simple method for writing a regulation name and identifying the most likely regulation number for your De Novo application.

Price: $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.

When is the Classification Rationale Webinar?

This webinar will be live on Thursday, July 11, 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. 

What you will receive in the Classification Rationale Webinar:

• Template for writing a Classification Rationale, Draft Regulation Name and Number
• Recording of live webinar
• Native PowerPoint Slide Deck
• Login Information (if purchased before Live Webinar)

If you would like to upgrade your purchase to our entire 510(k) Course, which includes templates and webinars for pre-submissions, 513(g) Classification Requests, 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 this 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.