Medical device safety is drawing intense scrutiny from global regulatory bodies, the press, professional literature and consumer groups. Task forces and working groups are examining potential changes to submissions and reporting requirements to ensure device safety, clinical trials are being required for 510(k) applications and many provisions are under consideration to foster FDA's efforts to ensure medical device quality.
Cheryl Shea-Frederick, Director of Regulatory Affairs at ArthroCare Corporation, will be discussing strategies for medical device recalls at the upcoming marcus evans’ Medical Device Safety Monitoring and Reporting Conference taking place January 17-18, 2013 in Las Vegas, NV.
marcus evans spoke to Cheryl before the upcoming conference. In her presentation, Cheryl will touch upon ongoing changes with regulatory requirements when reporting malfunctions and conducting device recalls. She will also expand on the role of the Health Hazard Evaluation and Health Risk Assessment in evaluating the need for a recall.
When it comes to the new FDA and international reporting requirements, medical device companies need to be aware of the expectations to reduce possibilities of product recall. “There are ongoing changes within the U.S. regulatory affairs landscape. Examples include new user fees implemented in October, the upcoming UDI initiative and potential taxation of medical devices” says Shea-Frederick.
“I try to put myself in FDA’s shoes whenever interacting with them or interpreting their guidance. I ask myself, “what’s important to them, what are they really asking for?” I think that it is also important to stay abreast on new recall activity within the industry, as well as Adverse Event/MDR reporting and FDA Warning Letters. It gives you an idea of the current “hot buttons” within the Agency.”
While the FDA has made significant progress on tracking drugs, it is not yet in a position to do the same thing for devices. The FDA has long acknowledged the need for a unique device identifier system, and got permission from Congress to set one up five years ago. No such system of ID-tags exists yet, but after several recent high profile medical device failures, the issue getting some attention from Congress.
So how does one manage a timely product recall? “We [ArthroCare Corporation] have developed internal procedures for identifying and managing potential recall situations. We utilize the FDA’s internal form for HRA/HHE evaluation to ensure that we have covered all bases regarding potential impact on health. We also utilize the FDA’s format for Recall Strategy and Recall Reporting, to ensure that we fully meet FDA requirements” says Shea-Frederick.
This marcus evans conference will focus on the challenges that are faced by these companies such as reporting systems, various methods of collecting data and meeting certain deadlines for reporting to the FDA. Attendees will also explore strategies and trends for recalls, corrections and removal of devices with defects.
What can you gain most from attending this event? Cheryl shares her thoughts on key takeaways from the conference: “I find that the value in these events is learning how other companies manage different types of regulatory/regulatory compliance issues. Delegates share what has worked and what can be done better; there is always room for improvement. In my mind, if you get a group of sharp people with varied experience in a room, the ideas can flow and generate new and exciting possibilities. The networking is always valuable as well.”
Cheryl Shea-Frederick is the Director of Regulatory Affairs at ArthroCare Corporation. She is a professional with over 20 years experience in the medical device industry, serving in various management positions within regulatory affairs, clinical programs, regulatory compliance and quality assurance. Her background encompasses both small and medium size companies, including 2 successful start-ups.
For more information, please contact Michele Westergaard at 312-540-3000 ext. 6625 or Michelew@marcusevansch.com.
About the Medical Device Safety Monitoring and Reporting
This unique event will take place in Las Vegas, NV from January 17-18, 2013. Industry leaders attending this event will benefit from a dynamic presentation format consisting of workshops, panel discussions and case studies. Attendees will experience highly interactive conference sessions, 10-15 minutes of Q&A time after each presentation, 4+ hours of networking and exclusive online access to materials post-event.
About marcus evans
marcus evans conferences annually produce over 2,000 high quality events designed to provide key strategic business information, best practice and networking opportunities for senior industry decision-makers. Our global reach is utilized to attract over 30,000 speakers annually; ensuring niche focused subject matter presented directly by practitioners and a diversity of information to assist our clients in adopting best practice in all business disciplines.