FDA Will Publish Metrics-Based Inspections Guides by Year End

Devicemakers will have 13 new product-specific guides by the end of the year to tell them what quality-related metrics FDA investigators will focus on during site inspections, agency officials said.

The guides aren’t new standards, but rather instruct investigators on specific quality metrics to review as part of quality system inspections. All branches of CDRH’s Division of Manufacturing and Quality — e.g., the cardiovascular device, physical medicine, orthopedic, neurology and dental device branches — are working on developing quality metrics.

The FDA will not release specific information on the topics and content of the 13 guides until they are published.

CDRH has been testing the new approach with a pilot program for manufacturers of battery-operated devices. Center staff spent the past two years talking to participating companies to correlate specific measures that predict quality, such as the ability of suppliers to meet manufacturing specs, with good manufacturing practice requirements checked during audits, Silverman said.

In the pilot, both CDRH staff and manufacturers received copies of the inspection guides, which address these “critical to quality” measures, said Silverman, who spoke at a session of the International Medical Device Regulators Forum semiannual meeting in Washington, D.C. Three inspections have been conducted under the pilot, and another three are in progress or scheduled to occur soon.
Manufacturers and inspectors involved in the pilot said it was helpful to know ahead of time what factors will be given the most weight in an inspection, and while the new focus requires more preparation on investigators’ part, it has resulted in greater time efficiencies during the inspection, the official said.

More guidance documents will follow as long as feedback remains positive, Silverman said. The agency plans to begin work on a Critical to Quality stakeholder forum by the end of the year to lay out further plans for quality metric guidance.

The inspection guides are part of the ongoing agencywide Case for Quality initiative, with its focus on encouraging quality through guidance versus penalizing companies for deviations identified during inspections. The shift is needed because the sheer number of device companies with products on the U.S. market has outpaced what the FDA can inspect on a regular basis, said Steve Solomon, associate director for global operations and policy.

Payers Looking at Quality

The agency is also expanding the Case for Quality initiative by gathering input from payers, investors, physicians and other stakeholders, Solomon said. Payers are particularly interested in improved device quality because the current lack of data makes it difficult to determine which devices perform best. And with no independent source of information on device quality, the market often favors rapid innovation that may not ultimately help patients, he said.

Not all results of the Case for Quality initiative need stem from the FDA, Solomon said. He suggested manufacturers consider collaborating to develop shared best practices, which would not necessarily be official regulations or guidances.

Eventually, the FDA might drop some quality-focused efforts by handing them to a dedicated third party, Silverman added. “The third party could come in, look at the quality measures and see how you did compared to your competitors. And then it would be up to the company to decide if they wanted to report that ranking to the FDA.”

Companies that did well in the third-party evaluation could see FDA enforcement benefits, such as lessened premarket scrutiny, Silverman said. — Elizabeth Orr

For more information about the FDA’s metrics-based inspections guides, check out FDAnews’ Ninth Annual Inspections Summit.

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