This 513g submission mini-course will give you step-by-step instructions for completing the FDA PreSTAR template.
513g mini-course ($300)
Please note: This mini-course 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). You can also purchase this mini-course through out #mdauditor website.
What you will learn in our 513g mini-course
The original 513(g) submission webinar was recorded on Friday, April 5, 2024, but this was expanded to include additional webinars and templates related to De Novo submissions.. The resulting mini-course includes 13 lessons. You can purchase it on-demand and watch the training as often as you wish. The mini-course explains what a 513g request is, and when you should be submitting a 513g request within your overall design plan. The mini-course reviews each of the content requirements in the FDA guidance document. The course 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. Please note that you can now use the most recent version of the FDA PreSTAR for a 513g request. This mini-course is also included in our larger 510(k) course. If you upgrade to the 510(k) course, please request a credit for this purchase.
What’s included with the 513g mini-course
The following templates and other documents are included with this mini-course. 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 template
- 513(g) Cover Letter Template
- 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 FDA 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)
All content deliveries will be sent via AWeber emails to confirmed subscribers or you can purchase through our #mdauditor website.
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 30+ 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 510k submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn,