CDRH Losing Device Expertise, Official Says

Building expertise at the FDA for medical devices to better identify problems in the field will require substantial resources, according to an agency director.

“Our device expertise in the field has shrunk. We need to grow that. We need to build that expertise from the ground up, and that’s a very big ticket item,” Timothy Ulatowski, director of CDRH’s Office of Compliance, said at the FDAnews Fifth Annual Medical Device Quality Congress.

Although the FDA is hiring new investigators for its food and drug facilities programs, “there will be additional activity in the device area as far as resources,” Ulatowski said.

Funding is a big part of the equation. Last month, President Bush signed a supplemental appropriations bill for fiscal 2008 that provides $150 million in additional funding for the FDA, including $20.1 million for CDRH and related Office of Regulatory Affairs (ORA) field activities.

As momentum builds for increased funding for the agency, ORA is undergoing a facelift. Almost all of its leadership is leaving, including Associate Commissioner of Regulatory Affairs Margaret Glavin, who is retiring, and Assistant Commissioner for Compliance Policy David Horowitz, who was recently promoted to assistant commissioner for policy for the FDA. Deputy Director Deborah Ralston also has left.

“It’s an entirely new leadership,” Ulatowski said. “It’s going to be an exciting time as not only people are changing but issues are changing.”