FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) hasn’t been around very long, but it’s doing a good job of demonstrating the value of the agency’s life-cycle approach to the regulation of medical devices.
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OIVD’s Gutman: Integrating functions.
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Formerly part of the Office of Device Evaluation (ODE), OIVD was launched three years ago as a separate entity within the agency’s Center for Devices and Radiological Health (Rockville, MD). According to OIVD director Steven Gutman, MD, the office has made significant strides toward integrating the critical regulatory functions of premarket review, compliance oversight, and postmarket surveillance into a single cohesive unit.
Earlier this month, OIVD released its annual report for fiscal 2005—its first such report as an entity separate from ODE. The report notes that the IVD sector is poised for significant growth as the era of molecular diagnostics and personalized medicine continues to steadily advance. “OIVD is up for the challenge of becoming an engaged and proactive member of this diagnostic revolution,” writes Gutman. “It is our hope that our role at the table will be one of facilitator and partner rather than obstacle. We are committed to the important mission of promoting and maintaining availability of safe and effective diagnostics for use in the medical marketplace.”
In terms of performance metrics, OIVD received a total of 666 submissions in FY05, a slight increase over the 659 submissions in FY04 (see Table I).
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Table I. Major submissions received, FY04–FY05. Source: FDA Office of Vitro Diagnostic Device Evaluation and Safety |
Regarding completions, some PMA submissions received in FY05 are still under review and were not included in the current report. FY04 PMA completion data were used for comparison with year-earlier figures (see Table II). Average total FDA review time from filing to approval (excluding withdrawals) for all original PMAs and supplements declined from 249 days in FY03 to 220 days in FY04. Average total elapsed time also declined in the same period—from 360 to 327 days (See Table III).
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Table II. Major submissions completed, FY04–FY05. Source: FDA Office of Vitro Diagnostic Device Evaluation and Safety |
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Table III. Average FDA review time and average total elapsed time, from filing to approval, for all original premarket approval (PMA) applications and panel-track PMA supplements (excluding withdrawals), FY01–FY04. Source: FDA Office of Vitro Diagnostic Device Evaluation and Safety. |
For all 180-day PMA supplements, average total FDA review time from receipt to final decision decreased from 145 days in FY04 to 57 days in FY05. Average total elapsed time decreased from 179 to 123 days. Average total FDA review time from receipt to final decisions for real-time PMA supplements increased from 34 days in FY04 to 47 days in FY05.
For products submitted for review via premarket notification (510(k), time to completion of premarket review increased slightly between FY04 and FY05 (see Table IV). FDA review time for 510(k) submissions increased from 59 days to 61 days, while total review time increased from 84 days to 88 days. The total elapsed time is still somewhat greater than the office’s best recorded performance of FY02, when FDA time and total time were 62 days and 77 days, respectively.
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Table IV. Average FDA review time and average total elapsed time, from filing to approval, for all premarket notifications (510(k)s) receiving substantially equivalent or not substantially equivalent decisions, FY01–FY05. Source: FDA Office of Vitro Diagnostic Device Evaluation and Safety. |
Overall, OIVD completed 572 submissions in FY05, compared to 613 in FY04, a decrease of 6.8%.
According to the report, OIVD has made excellent progress in implementing nearly all of the performance goals set by the Medical Device User Fee and Modernization Act of 2002.
In addition to performance data, the report features a sampling of IVD products, equipment, and systems approved during FY05. Also included are a list of IVD-related guidance documents and information about OIVD program initiatives, including patient safety and product quality, bioterrorism preparedness, electronic submissions, and OIVD advisory panel activities.
The report also notes availability of the online, searchable database of complexity categorizations assigned under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The database lists all commercially marketed in vitro test systems categorized by the Centers for Disease Control and Prevention (CDC) prior to January 31, 2000, as well as the tests categorized by FDA after that date.
Appendices of the report include an index of relevant publications, conferences, and events; a select list of IVD-related Web sites; and an OIVD organizational chart and staff roster. The detailed 46-page report is available at: http://www.fda.gov/cdrh/annual/fy2005/oivd.
© 2006 Canon Communications LLC
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