FDA National Forum “Case for Quality” A Big Success
Xavier Health Hosts FDA National Forum: The Case for Quality
The FDA selected Xavier Health and Xavier University to host the first ever FDA National Forum. A full-day program included an interactive session on FDA’s Case for Quality Initiative, led by representatives from the Center for Devices and Radiological Health (CDRH). The workshop promoted knowledge advancement and facilitate networking among regulatory professionals.
The FDA’s interactive forum provided the medical device community a chance to share thoughts on best practices, what works and what inhibits quality efforts, directly with FDA representatives. Attendees learned more about the initiative, timelines for short- and long-term goals, mechanisms for stakeholder involvement and plans for how this initiative will be implemented at the national and regional levels.
The FDA has shifted their focus away from regulatory compliance with the hope that the industry will do the same. The focus to create a quality product rather than just meeting regulatory standard is a priority. 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. The FDA’s Case for Quality will place more help to increase transparency, communication and establish root cause analysis and will rely on the participation of industry stakeholders to achieve true success.
The Case for Quality Initiative is part of the 2013 CDRH Strategic Priorities (Priority 4, Goal 4.1.1, 2013 CDRH Strategic Priorities) and the FDA National Forum set three strategic priority goals:
- 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 divisions through focused discussions with external constituents at two national forums and one local forum.