Special 510k Submission Webinar

This webinar explains the differences between Traditional and Special 510k submissions and shows how they impact the FDA eSTAR.

Special 510(k) Webinar ($79)

Special 510(k) Webinar

This webinar explains the differences between a Traditional 510(k) submission and a Special 510(k) submission. This webinar includes details of how the completion of the FDA eSTAR is different for a Special 510(k) as well as the differences in what documentation is required for a Special 510(k) submission.

Price: $79.00

When is the Special 510k Webinar

This webinar was live on Thursday, March 28, 2024. The session will also be recorded. You can purchase it on-demand and watch the training as many times as you wish.

Contents of Special 510k Webinar

Registrants will receive a confirmation email, and then after confirmation, they will receive login information for the live Medical Device Academy webinar by Rob Packard. This webinar is included with our 510k Course series. It was originally a free webinar but is now a paid webinar with updated content specific to the FDA eSTAR template. The purchase of this webinar includes the following contents:

• an invitation to participate in the live webinar (if you purchase before March 28)
• a recording of the webinar you can replay anytime
• the native slide deck for this webinar
• a copy of the FDA guidance for Special 510k submissions
• templates created by our team that are specific to a Special 510k

Additional Resources for 510k submissions

If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.

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 certification. 2009-2012, 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. His favorite part of his job is training others. He can be reached via phone 802.258.1881 or by email. You can also follow him on YouTube, LinkedIn or Twitter.