Medical Device Submissions Workshops

This spring, we're offering three back-to-back, online medical device submissions workshops, specifically for: 510(k), IDE and PMA submissions. These workshops provide attendees with real-world case studies, tips and best practices directly from FDA experts in a live, interactive format. This will be the only set of Submissions Workshops we offer in 2021, so don't miss out! 

510(k) Submissions Workshop
February 22 – 23, 2021

FDA and industry experts are coming together to review the basics of 510(k) submissions. This unique opportunity will help you better understand the FDA perspective on 510(k) submissions, from processes to approval to modifications. Throughout the 2-day workshop, you'll obtain actionable insights and strategies for assembling and streamlining an effective 510(k) submission.

Agenda topics include:

• FDA guidance for 510(k):
• Different types of 510(k)s
• Considerations for determining a product's regulatory route to market
• Factors to consider when planning and assembling a 510(k) submission
• Tips and hints on interacting with FDA during the 510(k) review process
• Deciding when to submit a new 510(k) for a device modification
• And more! View the full agenda here.

IDE Submissions Workshop
February 24, 2021

FDA and industry experts will share the guidelines governing when an investigational device exemption is required. Course instructors will review the purpose of an IDE, share tips for making the best use of pre-submission meetings, break down the components of an IDE submission and more. 

Agenda topics include:

• The purpose of an IDE
• Tips on making the best use of pre-submission meetings
• Components of a successful IDE submission
• Common errors and deficiencies in an IDE application
• The ins and outs of BIMO inspections
• And more! View the full agenda here.

PMA Submissions Workshop
February 25 – 26, 2021

Using real-world case studies, this workshop will walk you through the practical steps of filing a PMA and offer you actionable insights on how to best navigate the PMA submission process. Steps required, best practices and preparation for inspection will be covered throughout this two-day workshop.

Agenda topics include:

• Steps to develop a PMA submission strategy
• PMA Quality System best practices
• What to expect during a submission review
• Preparation needed for an advisory panel meeting
• Tips to prepare for an inspection
• Ins and outs of BIMO inspections
• How to deal with unexpected clinical outcomes, animal test results and adverse panel recommendations
• Management of approved PMAs
• Real-world case studies
• And more! View the full agenda here.

Hear from previous workshop attendees:

"The PMA Submissions Workshop is essential for anyone who is new to regulatory affairs. You will walk away with a greater understanding of how to prepare for a PMA submission. The speakers were very knowledgeable and the AdvaMed staff provided the best possible learning experience. Overall, I had a great experience and would recommend it to anyone in the medical device industry that works in regulatory."

"It was incredibly beneficial as a recent graduate to have had the opportunity to sit down with highly experienced professionals in the medical device field and focus on the topic of 510(k) submissions.  I'm now able to come back to my company with significant knowledge I didn't have before and get a jump start in applying it, rather than taking the time to figure out the process along the way. All in all, I came into the workshop knowing very few details about 510(k)s and left feeling like I could start on a submission."

Interested in learning more about other AdvaMed Events in 2021? Check out our event page here