Upcoming leadership vacancies at the Center for Devices & Radiological Health present an opportunity for the device center to revisit its organizational structure.

The planned departure of Office of Device Evaluation Director Bernard Statland, MD/PhD, Aug. 23 creates one opening. Statland is leaving the agency to complete legal studies at the University of Minnesota, where he earned a medical degree and a doctorate in biochemistry. The agency has yet to announce a replacement.

Statland was brought in as ODE director in July 2000, following the departure of Susan Alpert in October 1999 (¹ ¹ Also see "FDA Device Center Taps Agency Outsider Statland For Top ODE Post" - Medtech Insight, 19 June, 2000., p. 2). Alpert is now VP-Regulatory Affairs at Bard.

An agency outsider at the time he was recruited, Statland formerly served as medical director and CEO of North Shore-Long Island Jewish Health System, Consolidated Laboratory Network and ran a health consulting firm in Minneapolis.

ODE currently has three deputy directors - one for science and regulatory policy, Philip Phillips, and two for clinical and review policy, Kimber Richter, MD, and Daniel Schultz, MD - a structure that was put into place when Statland arrived. Naming Schultz as the third deputy director of ODE was one of Statland's first major appointments (² ² Also see "Radiology Review Division Chief Moves Up To ODE Deputy Director Post" - Medtech Insight, 11 September, 2000., p. 3).

Schultz has had responsibility for overseeing all six ODE premarket review divisions since Richter began her detail at the Office of Compliance in early 2001 (³ ³ Also see "FDA compliance" - Medtech Insight, 24 September, 2001., In Brief).

Philip Frappaolo, who recently returned from a detail in the CDRH director's office where he was overseeing the implementation of the device center's strategic plan, is serving as acting director of the Office of Compliance. Frappaolo is expected to retire by year-end.

With CDRH well into its five-year strategic plan, and with the device center's internal and external science reviews complete, it is unclear what effect the departures might have on the implementation of specific device center initiatives. One example is the proposed total product lifecycle pilot for in vitro diagnostics, which aims to bring together premarket and postmarket IVD experts throughout the center into a single IVD office. If implemented, the pilot could impact the organization of both the premarket and postmarket divisions of CDRH.

Reflecting on his time at CDRH during a recent interview with "The Gray Sheet," Statland praised efforts by CDRH staff, noting that turnaround times for premarket approval applications are expected to be "significantly shorter" in FY 2002 compared with one year ago. Average PMA review times in 2001 were 410 days. At the fiscal 2002 halfway point, review times were averaging about 365 days.

Statland also emphasized the need for greater financial support for the activities of the device center. He indicated that additional resources are necessary to continue the "efficient" handling of premarket submissions. The ODE director described medical device user fees as a "win-win" situation that could potentially allow ODE to hire additional staff and boost training, resulting in faster review times for industry.

If user fee legislation were to pass, it would likely lead to a major restructuring of CDRH and significant modification of the center's long-term goals and objectives. In the meantime, while the device center pushes for user fees as a hedge against anticipated future budgetary cuts, some reshuffling has already taken place to ease an existing resource crunch in the cardiovascular division.

Recently, in an effort to level workloads across ODE divisions, the anesthesiology and respiratory devices branch of the Division of Cardiovascular and Respiratory Devices (DCRD) was moved to the Division of Dental, Infection Control and General Hospital Devices (DDIGD). DCRD is now the Division of Cardiovascular Devices (DCD) and DDIGD has now become the Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGID).

The move has taken some of the pressure off the cardiovascular division, which had been struggling under a heavy workload, staffers say. The anesthesiology and respiratory branch receives a significant number of 510(k)s and investigational device exemption applications each year, officials note. A permanent director of DCD has not yet been announced.

CDRH In Transition? Premarket, Compliance Directorships In Flux

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