Shuren Looks to 2016 and Beyond in Device Center Update

While many stakeholders are excited about the 21st Century Cures Act recently passed by the House, industry should be mindful that the Senate version could be quite different.

“It will cost us money to implement,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. While the House bill would cover much of the implementation costs, it remains to be seen what the Senate will do.

Shuren cautioned that the FDA may need to divert resources from existing programs if the eventual bill signed by the president is different. He expects action in the Senate to rev up in coming weeks, with passage of a bill possibly next year.

Shuren made these remarks during an update of CDRH’s strategic priorities during the closing panel of AdvaMed 2015 in San Diego, Calif. He also made a few predictions on the center’s 2016-2017 strategic priorities, which will build on current accomplishments.

The director touted CDRH’s advances in strengthening the clinical trial enterprise, including increasing the number of early feasibility and first-in-human IDE studies submitted versus fiscal year 2013. The first nine months of 2015 year saw a 50 percent increase in the number of EFS submissions sent to CDRH, versus FY 2013.

Other areas are ripe for study:

• Quality by Design for medical device clinical studies;
• Improved IDE submission quality;
• Continued growth of the early feasibility study program;
• Leveraging evidence from clinical experience;
• Clinical trial simplification; and
• Use of modeling to reduce clinical trial size.

Shuren emphasized the need to simplify clinical trials. “What we’re finding is that most things measured are never used,” so instead of gaining data for the sake of obtaining it, “let’s focus on quality,” he said.

The CDRH director hopes to speed trials by incorporating modeling, which would allow sponsors to predict what the results will be, potentially saving time and money, he said.

Asked about President Barack Obama’s nomination of Robert Califf to head the agency, Shuren said, “I think it’s terrific. His vision for us is our vision.” — Elizabeth Hollis