The QMN Weekly Bulletin
Quality / Medical Devices / Regulatory Affairs

CDRH Looks to Targeted Inspections, Consultants to Up Compliance

March 7, 2014

The reorganization of CDRH’s Office of Compliance and creation of a Division of Manufacturing Quality has provided a shot in the arm to the center’s Case for Quality Initiative — fueling two pilot programs designed to increase inspection efficiencies without sacrificing quality, OC Director Steve Silverman says.

Speaking at the Feb. 20 FDLI medical devices conference, Silverman said the center is currently recruiting manufacturers of implantable battery-driven devices to participate in a program that will apply targeted inspections focused on factors that affect their products.

The five companies selected for the program will receive prioritized Form 483s at the end of the inspections, which are planned for later this year. CDRH will then analyze whether the audits resulted in time and resource savings for the companies and the center.

A second pilot on voluntary compliance improvement will give up to five devicemakers with known quality concerns that don’t pose a risk to patients a two-year break from FDA surveillance to define and resolve their problems with the help of outside consultants. The goal is to see whether this results in more time for the FDA to focus on companies unable to identify quality problems on their own, Silverman said. CDRH will co-manage the pilot with the FDA’s Los Angeles district office.

If successful, both pilots will be expanded, Silverman said. The names of the participating devicemakers will not be disclosed until after the pilots are concluded and only with their permission. CDRH has identified several companies that are interested in the battery pilot. The center is still determining whether enough interest exists to launch the voluntary compliance program.

The FDA is also “focused intently” on developing a forum where stakeholders can meet and discuss ways the agency can make inspections faster and more effective without sacrificing quality. The initiative was launched in 2011 to combat the perception that FDA compliance efforts were in “Groundhog Day mode,” Silverman said.

“We inspect, we issue citations, the manufacturers fix the problems, we inspect again and issue more citations — but the overall level of quality in the industry seemed to stay the same,” the OC director said.

CDRH’s ability to remedy the situation was limited by areas in which device complexity had outpaced regulation and by limitations on sharing information about device quality with outsiders. The result was that there was no reliable way for patients or caregivers to select devices based on quality, Silverman said.

On the manufacturer side, it was evident that quality and compliance were not always synonymous, Silverman added. FDA investigators found companies that had compliant quality systems but made poorer quality devices than their competitors, while others produced very high-quality devices but failed to satisfy regulatory requirements, he said.

Through quality initiatives, CDRH hopes to increase the overlap between devicemakers’ business and quality objectives and compliance.

The original goals of the Case for Quality initiative were enhanced quality, transparency and stakeholder engagement. Over the past three years, however, CDRH has increasingly seen stakeholder engagement as a mechanism to measure the other standards, rather than as an independent mechanism to judge quality.

Silverman credited the recent OC reorganization with allowing the Case for Quality to move forward by involving more staff in initiative management. “Historically, the initiative has been led by senior staff … which was a tremendous strain on our resources,” he said.

Medical Device Quality & Compliance Institute 2014: Quality Systems and Design Control Training is coming up this May. Are you still unsure about CDRH’s compliance push and how you should respond to it? Join in and find out.