FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to medical device manufacturers.

Quality Management Initiatives for Medical Device Manufacturers

FDA’s CDER continues to put a premium on quality when it assesses a medical device manufacturer’s operations and product. The latest initiatives charge regulators and medical device manufacturers to better work together to produce the safest products possible.

These and other initiatives impact medical device manufacturers in several ways. They include how to keep records, establish corrective and preventive action (CAPA) plans, and prioritize strategy based on defensible risk assessment.

Understanding the FDA Inspector’s Perspective

Keeping abreast of these changes will help medical device manufacturers have a better sense of what FDA inspectors will focus on during an inspection. Consequently, manufacturers can better understand the FDA’s overall enforcement system at the macro level.

Culture of Quality and Organizational Excellence

One of CDRH’s most significant initiatives is to promote a culture of quality and organizational excellence. “A manufacturer’s ability to design and make high-quality, safe and effective devices and CDRH’s ability to provide the necessary oversight to assure devices on the market are high-quality, safe and effective will increase as manufacturers and CDRH embrace a culture of quality and excellence throughout our respective organizations,” as outlined in its 2016-2017 Strategic Priorities – 2016 Accomplishments.

3 Key Elements Outlined

CDRH outlines three key elements of the initiative and its progress as of the end of 2016:

  • Quality Management Framework: CDRH completed development of its document control system (DCS). It will ensure that current and approved quality program and key processes documentation, such as standard operating procedures (SOPs), templates and process maps are widely disseminated.
  • Education and Training: CDRH became an American Society for Quality (ASQ) enterprise member. CDRH offered staff training and many FDA staffers earned ASQ quality certifications. CDRH tripled the number of staff with quality credentials. ASQ criteria will likely guide inspections and other FDA interactions with medical device manufacturers.
  • A case for Quality: CDRH will develop metrics and best practices designed to assess quality management system performance using data collected from medical device manufacturers and other stakeholders through all production stages.

Increased Focus on Patient Engagement & Real World Evidence

In the past few years, FDA leadership has also pushed for increased focus on patient engagement and feedback and continued use of real-world evidence in medical device approval and relabeling. This is also known as leveraging “real-world evidence.” Much of the FDA’s efforts to promote its usage is through an initiative called National Evaluation System for Health Technology, or NEST.

Real World Evidence-Based Regulatory Decisions Increased by 85 Percent

CDRH’s 2016 target was to increase premarket and post-market regulatory decisions that leveraged real-world evidence (RWE) by 40 percent versus its Fiscal Year baseline.

Ultimately, CDRH more than eclipsed its target for 2016 with RWE-based decisions increasing by 85 percent.

Real-World Evidence Final Guidance Coming

In the meantime, medical device manufacturers should look for a final FDA guidance later this year outlining how real-work evidence may be used to support pre-and post-market regulatory decisions.

In addition, it’s important to leverage several other informational resources for additional guidance. The FDA and CDRH produce several valuable documents designed to show enforcement trends. For example, FDA’s “2015 Annual FDA Medical Device Quality System Data” report shares data through 2015. It details trends in inspections, Form 483 observations and warning letter citations.


CDRH is walking the talk. They are implementing the same quality processes they expect from medical device manufacturers. Consequently, warning letters indicate enforcement trends where FDA regulators won’t accept what they perceive to be poor quality in a medical device manufacturer’s product or service. Recent warning letters further illustrate the need for medical device manufacturers to adopt a robust quality management system specifically built for FDA compliance like AssurX that will address the critical inquiries of FDA inspectors.

The Automating Your QMS white paper details common pitfalls, essential strategies and real world scenarios for medical device manufacturers when automating their quality management system.

The Automating Your QMS white paper details common pitfalls, essential strategies and real-world scenarios for medical device manufacturers when automating their quality management system.