The Food and Drug Administration (FDA) and Xavier University present MedCon, a medical device conference, April 30-May 3 at Xavier University.
The medical device industry and the FDA more than ever are faced with huge regulatory challenges to maintain patient safety. New technology leading to ground-breaking medical devices, including medical devices that require computer software and social media are creating new hurdles for the FDA in order to ensure patient safety. Congress and the FDA recently addressed these growing concerns by passing one of the largest pieces of legislation that will enhance the safety and quality of drugs in the United States – “The FDA Safety and Innovation Act” (FDASIA). The FDA/Xavier University MedCon Conference will bring together members from the FDA Office of the Commissioner with leading companies to discuss implementation of this new legislation and how it will impact current manufacturing practices of the medical device industry. In 2012, more than 300 attendees traveled from 4 countries and 25 states, representing more than 120 companies.
Xavier University collaborates with experts from the pharmaceutical industry and FDA leaders to foster innovation. Leading FDA officials, industry CEOs, congressional representatives, and global industry experts attending this year include:
• Dr. Jeffrey Shuren: Director, Center for Device and Radiological Health (CDRH)
• Christy Foreman: Director, Office of Device Evaluation, FDA
• Steve Silverman: Director, CDRH Office of Compliance
• Erik Paulsen: Congressman (MN), Member of the Ways and Means Committee
• Paul Brooks: Vice President Healthcare Solutions, BSI Product Services
• Monica Wilkins, Divisional Vice President, Abbott
The FDA/Xavier University MedCon Conference is part of Xavier University’s mission to make a difference in the communities we serve. The MedCon Conference focuses on maintaining quality and regulatory compliance by providing real solutions for the medical device industry. Xavier University aims for results that will uphold the FDA mission to maintain safe, available, and affordable drugs for patients in the United States.