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New FDA Focus – Case for Quality

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Question: I just heard about an FDA initiative for medical devices, called Case for Quality.  What is it and how is it different from the current Design Controls?

Answer: Design controls were enacted in 1997 by the FDA as a way to improve medical device quality.  However, they observed that products can be fully compliant yet still have poor quality and that quality products may not be fully compliant.

In 2011, the FDA created a program called Case for Quality after an analysis showed the same observations and problems continued to occur year after year, despite greater regulatory oversight.  At the same time, they observed companies that had a culture which identifies risks and drives quality improvements throughout the organization had better quality products overall.  This is analogous to the results seen by companies that fully adopted Total Quality Management (TQM) or other quality initiatives, some of which have been around for decades.

Some work has been done on the Case for Quality program.  This year the FDA included promoting a culture of quality and organizational excellence in the CDRH’s 2016-2017 strategic priorities, which includes Case for Quality.  Three core components are included in the Case for Quality program.

  1. Focus on Quality: treats compliance as a baseline, but also working with stakeholders to identify critical-to-quality practices that correlate to higher quality outcomes
  2. Enhanced Data Transparency: leverage data currently collected by the agency to support device quality
  3. Stakeholder Engagement: meet regularly with stakeholders to collaboratively solicit feedback and launch initiatives

As part of the FDA’s goals to promote a culture of quality and organizational excellence, a companion program has also been initiated, Voluntary Compliance Improvement Program (VCIP) Pilot.  In this pilot program, the FDA is allowing firms to voluntarily self-identify and correct possible regulatory violations instead of undergoing FDA routine surveillance inspections.

The FDA recognizes that a focus purely on compliance has not yielded the overall goal of safe and effective high quality medical devices.  By including quality excellence in their strategic goals, the FDA seeks to find better ways to shift the focus from ‘compliance only’ to ‘quality which is also compliant’.

Design controls provide the baseline for medical devices.  However, there is a real need for the medical device industry to focus on the quality of the product from design through manufacturing and distribution, instead of just compliance.  The Case for Quality program is part of that effort.

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