This webinar will help you identify when to request FDA pre-sub meetings and how to prepare your pre-sub request.
Do you know what an FDA pre-sub meeting is?
Do you know if the FDA expects a pre-sub meeting prior to every 510k submission?
You will learn the answer to both of these questions in this webinar. You will learn how to prepare for a pre-submission meeting, if you would benefit from an in-person meeting and when a teleconference call is more appropriate.
In this presentation, our speaker explains how to submit a request for an FDA pre-submission meeting in preparation for a 510k submission or De Novo submission. The presentation specifically explains how to integrate the pre-sub meeting into your design control and product risk management plan. Maybe you should not be submitting a pre-sub meeting request at all, but you need to know when and how to use pre-sub meetings to your advantage.
What will you learn in the FDA pre-sub meeting webinar?
- The format and content of your next pre-sub meeting request?
- When the best time is to request a pre-sub meeting?
- What should you never ask during a pre-sub meeting?
- What should you do if you disagree with the FDA during a pre-sub meeting?
Did you miss this live webinar? Get the full recording (including the Q&A) today.
Who should watch this webinar?
- Regulatory Affairs
- Product Development / R&D
You will be able to ask questions during this live webinar session. You will also receive a link for downloading the recording of the webinar.
Please Note: Purchase of the webinar includes the Native PowerPoint slide deck and the recording of the webinar. You will have the ability to share this content with anyone in your company—as many times as they wish.
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 the Author
Robert 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. Robert 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. 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 at 802.258.1881 or email. You can also follow him on Google+, LinkedIn or Twitter.