IMDMC Hosts FDA District Office Meet and Greet
02-12-2013
The ExpertRECALL team recently had the pleasure of attending a Meet and Greet with staff from the U.S. Food and Drug Administration’s (FDA) Detroit District Office.
The event had a great turnout with more than one hundred people attending and ready to meet district FDA staff. The program was hosted by the Indiana Medical Device Manufacturers Council, Inc. (IMDMC), an association of medical device manufacturers and other companies dedicated to promoting educational programs and the interests of medical manufacturers in Indiana and Washington, D.C.
Among the FDA Detroit District Office members that attended the event were:
- Art Czabaniuk – Detroit Deputy District Director; and
- Steven Barber – Director of Compliance.
The day-long session was moderated by Debbie Reece, Vice President of Corporate Quality and Compliance at Zimmer, a manufacturer of a host of surgical products including orthopedic, reconstructive, spinal and trauma devices.
A number of presentations were also given during the event, which provided an excellent overview of FDA’s approach to regulatory issues. The list of topics discussed included:
- The need for global corrective action;
- How to minimize potential regulatory violations documented as Form 483 observations during an FDA inspection; and
- FDA’s assertion that recalls point to violations of the Quality System Regulation (QSR) which is meant to help manufacturers ensure that their products consistently meet applicable requirements and specifications.
The presentations were a powerful reminder of Dr. Hamburg’s remarks the year she became the 21st commissioner of food and drugs. To be an effective regulator, FDA must be vigilant, strategic, quick, visible and transparent. And the agency continues to pursue those five touchstones as it modernizes its approach to regulatory issues facing not only the medical device industry, but also the pharmaceutical and food industries.
Indiana has a strong medical device community, and it’s always time well spent when leading companies, thought leaders, and regulators can get together and discuss where the industry is headed. And the IMDMC’s Meet and Greet program was an excellent way to keep everyone educated and start a healthy dialogue on the state of the medical device industry.
Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.
