Could Regulatory Science Raise The Bar For Industry?

Article preview from "The Gray Sheet"- August 29, 2011

FDA is pouring more time and money into the field of regulatory science, and device makers would be wise to wonder: how will this affect us?

Could Regulatory Science Raise The Bar For Industry?

Article preview from "The Gray Sheet"- August 29, 2011

Regulatory science is often touted as a way to make medical product development faster and more efficient. Advances such as computer modeling, for example, could help FDA and industry gather data about device performance with fewer clinical trials.

But advances in the field will bring some short-cuts and new responsibilities, according to Larry Kessler, former director of CDRH’s Office of Science and Engineering Laboratories, the device center branch that conducts regulatory science research.

Regulatory science will allow regulators to ask “the right questions” about safety and effectiveness, Kessler says, and in anticipation, “manufacturers should be asking those questions of themselves at the exact same time.”

“The bar is getting raised higher,” says Kessler, now chair of the department of health services at the University of Washington’s School of Public Health. “The more the agency knows about the way products work, the more questions they will tend to ask. I think they tend to be good questions, and important questions to ask.”

FDA’s current scientific leadership, on the other hand, disputes that regulatory science will raise the bar for device makers.

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