New initiatives at CDRH aim to help the agency take a greater emphasis on quality operations and less on compliance activities during quality system inspections, CDRH Division of Enforcement director Bill MacFarland told a Food and Drug Law Institute conference June 18.
A deeper quality focus is what is needed based on citations in recent Warning Letters, he said. For example, 85% of recent medical device Warning Letters cited Corrective and Preventive Action deviations and 60% cited design controls. These deficiency rates have been steady going back to 2003, MacFarland told FDLI. Most concerning are the design controls deviations, he said, because these are “the proactive quality tools where you are trying to build quality into devices and it would be more appealing to have a decreasing rate here.”
The current inspection process is a compliance-focused checklist that assesses how a firm meets the Quality System Regulation, MacFarland said. In moving forward, the goal is to build on that inspectional approach to provide more engagement points with industry “where we can have interactions on quality issues,” he said. “FDA will focus with firms on root cause analysis, designing quality into the product, and optimizing corrective actions.”
While in the hypothesis stage, MacFarland continued, CDRH’s current thinking is to develop a “common approach” with common terminology for reviewing root cause information. “I think we are confusing firms,” he said, adding that it will be a root cause approach where firms won't see a District office asking one set of questions regarding a problem with a device and CDRH asking another set of questions. “As we go forward, we will obtain feedback internally and with outside stakeholders to assess whether building a common root cause approach is the right direction.”
Initial activities to drive this change will include ongoing conversations with industry and stakeholders (such as forums, interviews, and surveys). MacFarland said CDRH is also interested in finding a way “to add emphasis on preventive quality and not just reactive quality. And when I say preventive, I'm thinking more of the upstream quality assurance activities and building quality into the design and ensuring that suppliers are capable of meeting their requirements and that manufacturing processes are capable rather than reacting to quality problems.”
Another initiative under development at CDRH is “comparative quality transparency.” MacFarland said better data transparency in being planned where stakeholders will see improved access to recall root cause data, Medical Device Reporting, and investigative histories. Internal Center analyses such as which types of firms have design control issues will be more readily available, he said, so stakeholders have better opportunities to make risk-based decisions.