The March program titled “Regulatory Changes in Devices” was moderated by Buket Grau, Bill Christianson, Sharon Murphy, and Melissa Clark.
Written by: Jean Thomas and Katrina Weigold
Thursday March 23, 2010
The March program titled “Regulatory Changes in Devices” was an engaging panel presentation. The panel was moderated by Buket Grau, Director of Strategic Marketing, Regulatory & Reimbursement for Stryker. The presenters were: Bill Christianson, WW VP of Regulatory Affairs at DePuy Spine; Sharon Murphy, Sr. Director, Regulatory Affairs at Covidien; and Melissa Clark, Director for Corporate RA, at Boston Scientific.
The presentation was divided into three parts. Bill Christianson presented an entertaining and historical overview of why and how the FDA came in to being followed by the basics on 510(k) legislation. The second presenter was Sharon Murphy who described the 510(k) challenges that precipitated calls for reform and why Congress, FDA, and the public are up in arms. The final presenter of the evening was Melissa Clark who spoke about the output from recent FDA and IOM public hearings on the 510(k).
These presentations were followed by an energetic Q&A session led by Buket. Some interesting and thought provoking questions from the audience were;
- “Does the current 510(k) process allow for safe and efficacious products to be put on the market?”
- “How are combination products handled?”
- “Is the 510(k) process considered a shortcut or loophole for getting a device approved?”
- “Has there been a call for reform from the public or from industry for increased transparency in the process?”
The program was well received with the following general statistics from the evening:
- The event met attendees' expectations, and was ranked 4+ out of 5
- All speakers were ranked 4 or higher out of 5
- Almost all attendees had enough time to network
- 64% of attendees are interested in a future program focused on device clinical trials