For Medical Device Professionals

FDA Compliance Officer: Industry, FDA Must Focus on Device Quality (Not Just Compliance)
by Arundhati Parmar,

Nov 28, 2012 | Free Downloads | email | Print

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Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc.

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Complying with regulation so that device makers avoid being slapped on the wrist by the U.S. Food and Drug Administration is a narrow effort compared with building high-quality devices that meet the needs of patients.

That's the distinction that Steve Silverman, FDA's top compliance officer when it comes to devices, made at a speech to a Minneapolis audience on Monday night [November 15, 2012].

"Compliance is just a baseline," he said. "High-quality devices is what is best for patients."

As Director of the Center for Devices and Radiological Health's Office of Compliance, Silverman is in charge of all the enforcement actions that the agency takes to ensure that device makers are complying with regulations.

However, in his speech outlining the agency-wide effort to build a quality framework, he explained that while the FDA will continue to enforce regulation, its success won't be judged by that enforcement work alone.

"The sum total of our success is not measured by the number of warning letters we issue, the number of seizures we make. ...," he said.

That's partly because the FDA inspects a fraction of device makers that fall under its jurisdiction globally. In the U.S., 66 percent of firms that the FDA is supposed to regulate are not inspected. Globally, the number is staggering: 95 percent of device firms are not inspected, Silverman said.

"We are outpaced by the industry that we regulate," he said.

And that has renewed a case for quality. He promised that the FDA, which has been historically focused on compliance, will be more deliberate about quality. One way that the FDA is hoping to do so is to carefully release data that can help patients and providers understand quality information between competing devices.

But he underscored that context is key to release of any such information that the FDA has internally because it doesn't want to be misconstrued as picking favorites.

"There is significant risk in doing this and so we have to provide context," Silverman said. "It's not the position of the agency to be a Consumer Reports. We don't want to put out a score."

The goal will be to provide data transparency so people can easily access the variety of data that the FDA has - they could be adverse event reports, inspection data and recall data among others.

But the FDA and CDRH doesn't want to see this effort in isolation. Silverman repeatedly talked of collaboration - not simply between industry and the agency, but among device vendors and between them and others who are invested in quality: doctors, payers, Centers for Medicare & Medicaid and patients.

"All of them have a use for reliable data," he said.

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