Events

Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 8-10, 2022
IDE Submissions Workshop: February 15-16, 2022
PMA Submissions Workshop: March 1-3, 2022

Register Now

Access FDA and industry experts while saving on travel costs and enjoying our interactive, livestreamed workshops from the comfort of your home or office!

Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 8-10, 2022
IDE Submissions Workshop: February 15-16, 2022
PMA Submissions Workshop: March 1-3, 2022

Register Now

  1. Overview
  2. Pricing
  3. Speakers

Medical Device Submissions Workshops

510(k) and De Novo Submissions Workshop: February 8-10, 2022
IDE Submissions Workshop: February 15-16, 2022
PMA Submissions Workshop: March 1-3, 2022

Register Now

Join us in Spring 2022 for our online Medical Device Submissions Workshops, including: 510(k), De Novo, IDE and PMA Submissions. This is the ideal introductory program for professionals who are new to regulatory affairs and want an incredible opportunity to learn more about regulatory requirements for bringing products to market.

We listened to your feedback and added a dedicated De Novo portion to the 510(k) Submissions Workshop! We also added a new feature this year to encourage collaboration with peers and connect with speakers: Applied Learning Breakout Discussions. These speaker-led, 75-minute sessions will allow attendees to apply the knowledge they gained and ask any final questions.  

This will be the only set of Submissions Workshops we offer in 2022. Don’t miss out on this unique opportunity to access FDA and industry experts while saving on travel costs and enjoying our interactive, livestreamed workshops from the comfort of your home or office. AdvaMed members can also take advantage of the group discount.

Who should attend?

  • Medical device professionals new to the FDA regulatory submission process
  • Regulatory Affairs Professionals
  • Regulatory Compliance Professionals
  • Quality Assurance Professionals
  • Regulatory Affairs Rotational Associates

510(k) and De Novo Submissions Workshop
February 8-9, 2022
Applied Learning Breakout Discussion: February 10, 2022

Gain strategies for assembling and streamlining effective 510(k) and De Novo submissions from FDA and industry experts. Attendees will also obtain insight into FDA’s perspective on the submission review process.

This workshop will cover:

  • Law and regulations guiding the use of 510(k) and De Novo submissions
  • Factors to consider when planning and assembling a submission
  • Tips and hints for interacting with FDA during the review process
  • FDA’s process for reviewing 510(k) and De Novo submissions
  • Considerations after 510(k) clearance is obtained or De Novo classification is granted
  • And more!



IDE Submissions Workshop
February 15, 2022
Applied Learning Breakout Discussion: February 16, 2022

FDA and industry experts will share the guidelines governing when an Investigational Device Exemption (IDE) 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.

This workshop will cover:

  • 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
  • Developing an IDE strategy
  • Optimizing the pre-submission meeting
  • The ins and outs of BIMO inspections
  • And more!



PMA Submissions Workshop
March 1-2, 2022
Applied Learning Breakout Discussion: March 3, 2022

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.

This workshop will cover:

  • 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
  • How to deal with unexpected clinical outcomes, animal test results and adverse panel recommendations
  • Management of approved PMAs
  • And more!



“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.”

-Rotational Associate, Regulatory Affairs, Integra LifeSciences

Registration Pricing

Register before January 14 to save $100 off registration with our early bird pricing. Click here to check if your company is an AdvaMed member.

510(k) and De Novo Submissions Workshop
  • AdvaMed Member Companies: $1195.00
  • AdvaMed Accel Member Companies : $550.00
  • Government /Nonprofit: $550.00
  • Non-Members: $1595.00
IDE Submissions Workshop
  • AdvaMed Member Companies: $595.00
  • AdvaMed Accel Member Companies : $450.00
  • Government /Nonprofit: $450.00
  • Non-Members: $850.00
PMA Submissions Workshop
  • AdvaMed Member Companies: $1195.00
  • AdvaMed Accel Member Companies : $550.00
  • Government /Nonprofit: $550.00
  • Non-Members: $1595.00



Group Discount

AdvaMed members with 3 or more registrants can save an additional 10% off the AdvaMed member rate by using the code GROUP10.

*Discounts must be applied at time of registration

“The AdvaMed Submissions Workshops were very informative and helpful. In particular, hearing from experts in the regulatory field and representatives from the FDA was a great plus. It is one thing to just read the regulations, but it is extremely beneficial to have first-hand guidance from the experts.”

-Regulatory Affairs Manager, Terumo Aortic

Workshop Speakers

510(k) and De Novo Submissions Workshop
  • Tony Blank, AtriCure
  • Angela DeMarco, FDA
  • Holly Drake, Dexcom
  • Quynh Hoang, King & Spalding
  • Sally Maher, Sally Maher Consulting
  • Michelle Monroe, Dexcom
  • Ken Skodacek, FDA
  • Peter Yang, FDA
IDE Submissions Workshop
  • Tony Blank, AtriCure
  • Jaap Laufer, Emergo by UL
  • Albert Rodriguez, FDA
  • Jayna Wiebel, FDA
PMA Submissions Workshop
  • Jhumur Banik, FDA
  • Tony Blank, AtriCure
  • Jennifer Bolton, Boston Scientific
  • Kenneth Chen, FDA
  • Quynh Hoang, King & Spalding
  • Dharmesh Patel, FDA
  • Gerry Prud’homme, Hogan Lovells
  • Ken Skodacek, FDA

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