The FDA eSTAR requires you to attach human clinical study reports and summarize how it supports substantial equivalence.
Human Clinical Study Webinar ($79)
When is the Human Clinical Study Webinar?
This webinar was live on Thursday, February 8, 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.
Why you should register for the Human Clinical Study Webinar?
You will learn where your human clinical study information is attached in the FDA eSTAR, what additional information you need to attach to the eSTAR template, and how to answer questions about:
- Patient-reported outcomes (PROs)
- Patient-preference information (PPI)
- GCP Statement of Compliance
- Waiver requests for OUS studies
We will also discuss what questions to ask the FDA during a pre-submission meeting to ensure you do not need to repeat your human clinical study.
What you will receive:
- an invitation to participate in the live webinar (if you purchase prior to February 8)
- a recording of the webinar you can replay anytime
- the most recent version of the template for human clinical study protocols (see SYS-009)
- the native slide deck for this webinar
If you would like to ask specific questions about preparing the human clinical studies, please submit them via email or schedule a call using the calendly app on our contact us page. All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Human Clinical Study Webinar. If you have company-specific questions, please send me a request to set up a private call to discuss your specific issues.
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. 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.