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FDA Outlines Critical Quality Measures

Case for Quality is an initiative launched by FDA to shift focus from compliance to quality in medical device design and production. In an OMTEC 2015 presentation, representatives from FDA’s Center for Device and Radiological Health (CDRH) outlined the steps to Critical to Quality (CtQ) measures—one component of Case for Quality—and other initiatives of particular importance to orthopaedic device manufacturers.

FDA launched Case for Quality in 2011 with three core components: focus on quality, enhanced data transparency and stakeholder engagement. CtQ is a priority of component one, with FDA working with stakeholders to promote practices that correlate to higher-quality outcomes. The Agency also seeks to use these practices to streamline inspections.

Specifically, CtQ measures refer to key characteristics and features of a device that relate to overall quality based on manufacturing, design, supplier control, etc., according to William MacFarland, Director of the Division of Manufacturing and Quality within the Office of Compliance.

CtQ began as an inspection pilot in which FDA built CtQ information documents by combining technical information for a particular type of device with inspectional guidance, then sharing this information with investigators and firms willing to volunteer in inspections. This was completed in 2014.

“Our focus was not to change the method for an inspection,” MacFarland said. “The Quality System Inspection Technique (QSIT) still applies, but we wanted to promote more engagement with quality itself. Feedback from investigators suggested that this did promote more discussion of quality. One possible downside is that when we write this information and call it inspectional guidance, there is the perception that this is the test for the inspection.”

Rather than serving as the inspection test, CtQ helps the investigator get up to date on a particular device, gaining clarity on critical characteristics and features, MacFarland said.

“We wrote it in such a way that the investigator knows it doesn’t replace QSIT, but just interfaces with it,” he said.

Currently, FDA endeavors to make 13 documents public on CtQ inspections.

“Going forward, you’ll see more CtQ information documents, but don’t assume that the intent is inspectional in nature,” MacFarland said.

Further, FDA is determining how to use the concept of CtQ in a Premarket Approval (PMA) and will soon announce a PMA CtQ pilot.

“Rather than a normal pre-approval inspection to approve the PMA, we will confirm the CtQ information, confirm the controls with CtQ and defer everything else normally associated with a pre-approval inspection to post-approval. Expect to hear more from that soon,” MacFarland said.

To illustrate how CtQ documents are created, Nazia Rahman, a biomedical engineer in the Physical Medicine, Orthopaedics, Neurology and Dental Devices Branch of the Division of Manufacturing and Quality within the Office of Compliance, walked through the four-step process that reviewers will use.

1.  Identify top 10 key characteristics for the device.

“We’ll look at the device and its background, identifying the user, end user and key failure modes of the device,” Rahman said. “Then we’ll use those key failure modes and how they affect the device to identify those characteristics that are important to the device.”

2.  Identify how these characteristics are controlled in design and manufacturing.

“We observe documents such as essential design outputs, supplier agreements and acceptance testing to learn what firms use to ensure that these key characteristics are meeting their key specifications,” she said.

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