Agency announces working together with Biocom in an effort to speed up review process for devices; CDRH chief also calls for more collaboration in medical devices industry. 

The U.S. Food and Drug Administration is partnering with San Diego-based life sciences trade group Biocom to speed up the review process for medical devices. 

Speaking with reporters last week, Joe Panetta, Biocom's president and CEO, and Center for Devices and Radiological Health’s Jeffrey Shuren announced that they are working informally to redesign the medical device approval process to eliminate cumbersome and unnecessary steps. Shuren said that FDA is looking for the same arrangement with other trade groups all over the United States.

Speaking of some of the challenges that FDA is facing in terms of keeping pace with new technologies, and high staff turnover, Panetta said that the medical device industry needed, “clarity, predictability and transparency.”

Shuren on his part offered that FDA should limit its inquiries to matters that reviewers “need to know” to make sure products are safe and effective instead of asking questions about things that are “nice to know.” 

He also encouraged device makers to collaborate more and share information on standards set for product development. While manufacturers use their own internal standards for proprietary reasons, keeping this information confidential, wastes resources, Shuren felt. “If we have five sponsors of medical devices, all developing a device and all developing their own independent assessment of the device at that stage, they're investing money unnecessarily,” he said. 

Such collaboration is especially critical for devices which need to work together, in which case, aspects of interoperability and preventing interference become important, the CDRH director pointed out.