Medical Device & Diagnostic Industry

Washington

Wrap-Up

Enforcement by the Numbers
155 9

Number of device-related warning letters Number of device-related seizures,

issued in FY 2007 injunctions, or civil money penalties

in FY 2007

0

Number of seizures and other

enforcement actions in FY 2008

134

Number of device-related warning letters

issued in FY 2008

to the next steps. ”

Schultz said the top priority in FY 2009 is to develop and begin implementing a CDRH import safety strategy.

Schultz said developing a unique device identification (UDI) system also remains a priority for the center, and this is receiving increased attention after being added to FDAAA. He said that CDRH is now well into developing a regulation, which will require medical devices to bear a UDI to assist in identifying and, if necessary, recalling problematic devices, as mandated by the law. “This has to happen sooner rather than later,” he said.

Clinilabs Chief
Medical Officer
Heads New FDA
Unit

FDA has selected Jonathan Sackner-Bernstein, MD, chief medical officer of contract research organization Clinilabs, as CDRH’s new associate director for postmarket operations.

Since Sept. 2, he has been overseeing the center’s recently created matrix structure, which comprises 13 networks each responsible for a specific product category or activity.

“Each network brings together experts from various functional areas within the center, spanning premarket review to compliance and postmarket surveillance, forming cohesive groups focusing a wide variety of expertise on identifying, analyzing, and acting on specific postmarket issues,” an agency statement said.

“Dr. Sackner-Bernstein will supervise the work of the networks by providing clear direction and priorities, fostering the development of a common vision, and clarifying roles and responsibilities. As a member of the center’s senior leadership team, he will also act as a liaison between the networks and senior center management.”