This 513g submission webinar will give you step-by-step instructions for completing the FDA PreSTAR v1.0 template.
513g Submission Webinar Bundle ($79)
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 513g request webinar
This webinar was recorded on Friday, April 5, 2024. You can purchase it on-demand and watch the training as often as you wish. 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.
What’s included with the 513g submission webinar bundle
The following templates and other documents are included with this webinar bundle. Several of the templates provided are only required for a De Novo submission. However, it is recommended to submit each of these documents as a draft if the anticipated regulatory pathway is a De Novo Classification Request.
- FDA PreSTAR v1.0 Template
- 513(g) Cover Letter
- Draft IFU Template
- Draft Label Template
- Risk Mitigation Table (required for De Novo)
- Alternative Procedures & Techniques (required for De Novo)
- Efforts to Identify Potential Predicate Device (required for De Novo)
- Classification Rationale as Class 1 or 2 (required for De Novo)
- Proposed Special Controls (required for De Novo)
- Benefit/Risk Analysis Considerations (required for De Novo)
- FDA Guidance for 513g Submissions
- Native Slide Deck (24 slides)
- Recording of the Presentation (April 5, 2024)
The presentation was 58 minutes in duration. All content deliveries will be sent via AWeber emails to confirmed subscribers.
Other resources
If you need additional help preparing a 513g submission, please review our blog on 513g submissions or schedule a call with a member of our team.
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.