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FDA Compliance

Quality Management Insights for Medical Device Manufacturers

CDRH is walking the talk and expects device manufacturers to do the same

Published: Wednesday, May 31, 2017 - 12:01

The 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.

The CDRH 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 work together more to produce the safest products possible.

These and other initiatives affect 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 ensure 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,” notes the CDRH in its 2016–2017 Strategic Priorities—2016 Accomplishments.

Three key elements outlined
The 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 its 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.
• Case for quality: CDRH will develop metrics and best practices designed to assess quality management system (QMS) performance using data collected from medical device manufacturers and other stakeholders through all production stages.

Increased focus on patient engagement and real-world evidence

During the past few years, FDA leadership has also pushed for increased focus on patient engagement and feedback, and continued use of real-world evidence (RWE) 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.

RWE-based regulatory decisions increased by 85 percent
CDRH’s 2016 target was to increase premarket and post-market regulatory decisions that leveraged RWE by 40 percent vs. its fiscal year baseline. Ultimately, CDRH more than eclipsed its target for 2016 with RWE-based decisions increasing by 85 percent.

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

In addition, it’s important to take advantage of other informational resources for additional guidance. The FDA and CDRH produce several valuable documents designed to show enforcement trends. For example, the 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.

The CDRH is walking the talk. It’s implementing the same quality processes it expects from medical device manufacturers. Consequently, warning letters emphasize enforcement trends indicating that 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 QMS specifically built for FDA compliance like AssurX that will address the critical inquiries of FDA inspectors.


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AssurX Inc. develops quality management and regulatory compliance software solutions to help companies in any industry exceed quality expectations, ensure compliance, manage risks, and better govern their enterprise. AssurX solutions securely handle manufacturing defects, complaints, change control, regulatory compliance, supplier quality, audits, risk, corrective and preventive actions, and more.