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Compliance In Focus
Posted by John Lehmann on Thu, Oct 25, 2012

Change Your Focus from Device Compliance to Device Quality

Change your focusIn a recent speech in Minneapolis, Steve Silverman Director of the FDA’s Center for Devices and Radiological Health’s Office of Compliance, urged the industry to expand their focus beyond compliance and build high-quality medical devices.  The speech in was based on the agency’s focus on building a quality framework.  Silverman explained that while the FDA will continue to enforce regulation, its success won’t be judged by that enforcement work alone.

In an article in MedCity News, Silverman indicated that compliance with the regulatory framework is a baseline, but high-quality devices are in the best interest of patients.  Historically the FDA has been focused on compliance.  The challenge is that the FDA only inspects a fraction of the firms that fall under its jurisdiction globally.  Silverman indicated that 66% of firms are not regulated and 95% of firms are not inspected globally, which is a staggering number.

It’s been an ongoing mission of FDA to provide data transparency so people can easily access the variety of data including:

  • Adverse event reports
  • Inspection data
  • Recall information among

Silverman also noted it’s important to release information in a highly organized and consistent manner so that patients can compare medical devices and make informed decisions about possible treatments.  “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 is to build a collaborative environment among all groups.  What are your thoughts on this topic? Do you feel it’s important for the FDA to expand their focus beyond compliance?  Or are they getting involved in areas where they do not belong.

Share your thoughts below.

Photo Credit:  Cayusa

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Topics: Device Compliance, Device Quality, Steve Silverman


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