2017 ReGARDD Forum on Medical Devices

April 12, 2017 - 10:30am
April 12, 2017 - 1:30pm


The Duke Office of Regulatory Affairs and Quality (ORAQ) & Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)

The 2017 ReGARDD forum will take place in Duke North Lecture Hall 2001, with the following key presentations:

Tips for Success in Medical Device Premarket Submissions to FDA

Heather Rosecrans, FRAPS | 10:30am

This presentation will:

  • Provide valuable lessons learned from the former FDA Director of 510(k) Premarket Notification Staff
  • Cover what to expect and how to prepare for early interactions with the FDA
  • Give an overview of when to submit 510(k) and PMA applications


The Medical Device Reimbursement Life Cycle: Strategic Reimbursement Planning from Clinical Development to Commercialization

Jo Ellen Slurzberg | 12:00pm

This presentation will:

  • Provide an overview of how clinical trials, and some investigational devices may be eligible for reimbursement by Medicare and private insurers
  • Cover the inclusion of strategic reimbursement objectives to the clinical development plan
  • Introduce how clinical trials may be aligned to both regulatory and reimbursement goals


Parking Information: Parking is available on the corner of Fulton Street and Erwin Road in Parking Garage II at a rate of $2.00/hour or $8.00/day. Upon exiting the parking garage, enter through the main doors of Duke University Hospital and take the elevator to the second floor. Exit the elevators and continue across the bridgeway to Duke North Lecture Hall 2001.



Duke North Lecture Hall 2001