April 30, 2013
8:00 AM - 4:00 PM
The "Case for Quality" Initiative
FDA National Forum Event Details
- When: April 30, 2013
8:00 AM - 4:00 PM
- Where: Xavier University's Cintas Center, Banquet Facility
1624 Herald Avenue, Cincinnati, Ohio 45207
- Cost: $500 per person
- Full day forum.
- Pre-meeting material from the FDA.
- Post-forum summaries and materials.
- Breakfast, lunch and breaks.
- Important to recognize: The FDA National Forum takes place the day before the annual FDA/Xavier University Medical Device Conference (MedCon).
- MedCon begins April 30 with an evening reception from 5:00 - 7:00 PM at the Hilton Netherlands Plaza Hotel directly following the forum.
- MedCon conference sessions occur May 1 - 3 on the Xavier University campus.
- Hotels in Cincinnati are practically sold out on April 29 due to large conventions in the area.
Sponsored by the QARA Institute.
What is the FDA National Forum?
- The Case for Quality Initiative is part of the 2013 CDRH Strategic Priorities to "identify and prioritize systemic practices that advance device quality."
- The FDA National Forum at Xavier University on April 30 is part of the fulfillment of these strategic priority goals.
True success of this program relies on the participation of industry stakeholders to ensure that complete transparency and open communication is achieved.
- The FDA has set three primary tasks to advance this initiative (Priority 4, Goal 4.1.1, 2013 CDRH Strategic Priorities):
- By September 30, in collaboration with external constituents, identify and publicize systemic practices that are linked to device quality outcomes, including steps that CDRH and external constituents can take to support and adopt these practices.
- By September 30, publicize two quality-related medical device data analyses, such as trends in the types and root causes of device recalls.
- By December 31, inform quality-related regulatory devisions through focused discussions with external constituents at two national forums and one local forum.
About the Case for Quality Initiative
The FDA is shifting their focus away from regulatory compliance with the hope that the industry will do the same: focus on creating a quality product rather than just meeting regulatory standards. Over the past seven years, there has been a consistently high number of warning letters with design control or CAPA violations - causing the FDA to question their current methodology to encourage production of quality medical devices. Therefore, the FDA is starting an initiative that places more focus on quality by increasing transparency, communication and establishing root cause analysis: The Case for Quality.
May 1 - 3, 2013
Premiere Medical Device conference occurring the day after the FDA National Forum.
MedCon Congressional Keynote Speaker
Congressman Erik Paulsen
MedCon FDA Keynote Speaker
Dr. Jeff Shuren
Director, Center for Devices and Radiological Health (CDRH), FDA
MedCon 2013 Plenary Topics
- Workshop with the Regulators: Total Product Lifecycle Analysis
- Global Product Strategy
- How to Successfully Launch a Product in Central and South America
- FDA Safety and Innovation Act - Strategy and Timeline
- Unique Device Identification
- Industry Impact of New EU Regulations
- The Case for Quality: Office of Compliance Update
- Office of Device Evaluation Top Priorities
- FDA Investigation Insights
Register for MedCon 2013
Registration is separate from the FDA National Forum.
MedCon Break-Out Workshops
- Afternoon Workshop with the FDA: Navigating the Total Product Lifecycle
- PMAs: The Pre-Submission Program, Meetings with the FDA, New Guidance Documents and
- Compliance Initiatives
- 510(k) Delays: Is it FDA or Quality?
- How to Get a Product into the European Market: The ABC's of a CE Mark and Clinical Evaluations
- Combination Products: FDA Initiatives
- Software and Mobile Apps: When are they a Device and What are the FDA's Expectations?