FDA eSTAR will automatically generate a 510k summary. Should you use that feature or create a 510k statement instead?
510k Summary Webinar ($79)
When is the 510k Summary Webinar?
This webinar was live on Thursday, January 11. The session will also be recorded. You can purchase it on-demand and watch the training as many times as you wish.
Why you should register for the 510k Summary Webinar
The format and content requirements for a 510k summary have not changed, but the FDA eSTAR now allows you to generate a 510k summary automatically. You will learn where the FDA eSTAR is collecting information from in order to generate the summary automatically. We will review the guidance from the FDA and provide an analysis of multiple 510(k) summaries for a variety of device types. We will also discuss when it makes sense to use a 510k statement and how to create your own 510k summary using our template.
What you will receive
- a recording of the webinar you can replay anytime
- the most recent version of my templates for a 510k Summary and a 510k Statement
- the native slide deck for this webinar
There are 34 slides in the presentation. The presentation was 47 minutes in duration. If you would like to ask specific questions about preparing a 510k Summary or Statement, 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 510k Summary 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 802.281.4381 or by email. You can also follow him on Google+, LinkedIn, or Twitter.