This 513g request webinar explains how to prepare your FDA request, and you will also receive a complete set of templates for your 513g request.
The 513g request webinar was recorded by Rob Packard on November 24, 2019. You can download the webinar recording for free if you complete the form below. You will also receive a link for all of our 513g request templates.
What you will learn in our 513g request webinar
The webinar explains what a 513g request is, and when you should be submitting a 513g request within your overall design plan. The 513g request webinar reviews each of the content requirements in the FDA guidance document. The webinar includes a brief explanation of the requirements for obtaining a small business discount on the FDA user fee for a 513g request. Finally, you will learn about the FDA eCopy requirements for a 513g request.
Downloads included with the webinar
In addition to the native slide deck and a recording of the webinar, the webinar also reviews each of the templates that are provided in our dropbox folder for you to download. The downloads includes the FDA guidance for 513g requests too.
If you need additional help with preparing a 513g request, please review our blog on 513g requests.
About Your Instructor
Rob Packard is a regulatory consultant with 25+ years 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. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’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 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.