This webinar will help you compare the benefits of the FDA STeP vs Breakthrough Device Designation program for novel medical devices.
STeP vs Breakthrough Device Designation Webinar ($149)
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After verifying the transaction, please check your email for the download (including your spam folder).
What you will learn in our STeP vs Breakthrough Device Designation Webinar
This webinar will explain the advantages associated with receiving approval for the STeP application or receiving Breakthrough Device Designation. You will also learn what the required contents and format are for both submissions. Both are submitted to the FDA electronically as an FDA eCopy (i.e., not eligible for FDA eSTAR yet). However, the first document in either submission is unique, because it includes your justification for meeting the criteria for either status.
What’s included with the STeP vs Breakthrough Device Designation Webinar
In the Dropbox folder, we include the following files:
- Breakthrough Designation Request Template
- STeP Application Template
- Device Description (for non-IVD)
- Device Description (for IVD)
- Label Template
- IFU Template
- Native Webinar Slide Deck
- FDA Guidance for Breakthrough Devices Program (2023)
- FDA Guidance for Safer Technologies Program (STeP)
- Recording of Webinar
Q&A
Please submit questions to me by email at rob@fdaestar.com regarding the STeP vs Breakthrough Device Designation Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
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 802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.