At the recent Association for Medical Diagnostic Manufacturers (AMDM) Annual Meeting in Bethesda, MD, Don St. Pierre used the introduction of the workshop’s FDA Round Table panelists to update the audience on the much heralded reorganization of OIR. Don noted that the workload in the Division of Immunology and Hematology (a work horse responsible for a wide variety of new molecular diagnostics and companion diagnostics as well as all new immunology, hematology, pathology and flow cytometry diagnostic devices) had become too much for one work group. Hence a decision to sub-divide this unit into two separate work groups: the Division of Molecular Genetics and Pathology (DMGD) and the Division of Immunology and Hematology (DIHD).
Maria Chan will continue to provide leadership as Director of DIHD aided by Lea Carrington as Branch Chief for Hematology and Elizabeth Stafford as Branch Chief for Immunology and Flow Cytometry. Panelist Reena Phillip was introduced as the new Director for DMGD. Aiding her are two new Branch Chiefs: Yon-Fu Hu (Molecular Pathology and Cytology Branch) and Donna Roscoe (Molecular Genetics Branch). In addition Don announced another change of note: Katherine Serrano will replace Carol Benson as Deputy Director of the Division of Chemistry and Toxicology (DCTD). Carol retired in December 2013.
OIVD/OIR has historically adapted its organizational structure to meet the changing needs of the IVD industry and medical practice. For those of you following IVD regulation long enough to recall, in 2001 CDRH unveiled a strategic plan to regulate medical devices through the Total Product Life Cycle (TPLC), with the intent to strengthen the connections between the disparate programs in CDRH responsible for premarket review, compliance and post market surveillance. The IVD premarket work group (then known as the Division of Laboratory Devices) was selected to pilot this initiative.
After considering a variety of options for new approaches to old regulation, in November 2002, CDRH launched a new office, the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). The new office represented a combination of work and workers previously assigned to three separate Offices: the Office of Device Evaluation, the Office of Compliance, and the Office of Surveillance and Biometrics. For the first time in the regulatory history of devices, all functions for a medical device product line (IVDs) were orchestrated from a single unit and a common technical base.
Over time the program evolved to improve standardization of reviews, implementation of least burdensome practices, expansion of the pre-IDE program, and expansion in the use of new regulatory tools such as de novo classifications.
OIVD expanded its scope in January 2010 adding the premarket unit responsible for Radiology reviews to OIVD. By October 2013 the agency had also fully incorporated all of its post-market radiological health regulatory programs into its newly-named Office of In Vitro Diagnostics and Radiological Health (OIR). Technologies for in vitro and in vivo imaging devices were finally combined into an expanded work unit designed to assure consistency as well as continue to promote transparency in the regulation of an ever growing menu of diagnostic device. The spirit of TPLC seemed alive and well in this new CDRH office.
Today OIR has grown significantly (FTE approaching 300) and continues to flourish under the direction of Alberto Gutierrez with Don St. Pierre and James Woods serving as Deputy Directors. Rounding out the senior management team are two additional Deputy Directors: Mary Pastal, Deputy for Radiological Health, and Elizabeth Mansfield, Deputy for Personalized Medicine. Given the continued explosion in diagnostic technology and the heightened need for OIR to maintain flexible and balanced regulation, these changes in its organization and additions to its management staff seem well timed. They provide another illustration of the commitment and ability of the agency to keep abreast of the changing world of science and regulation needed to assure new diagnostic devices are safe and effective.