FDA Cites Improvement in Meeting Performance Goals

In its report for fiscal year 2005, the Office of Device Evaluation (ODE) in FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD) says it is meeting—and in some cases exceeding—nearly all of the performance goals set by the Medical Device User Fee and Modernization Act of 2002.

During the 12-month period covered by the report, ODE received 8714 major submissions, compared to 8536 in fiscal 2004, a year-to-year increase of 2.04% (see Table I). Of note is the growth of 513(g)s over the 10-year period reflected in the report's data. A 513(g) is a request for information regarding FDA regulatory requirements applicable to a device. In fiscal 2005, 313 513(g)s were submitted, a 14% increase over the number of 513(g)s received in fiscal 2004 and double the number received in fiscal 2003. In 1995, there were only two 513(g) submissions.

In fiscal 2005, ODE completed work on 8272 submissions, down 3.51% from the 8573 submissions completed the previous year. In its report, ODE compared performance data on premarket approval (PMA) applications from fiscal 2004 and fiscal 2003, because some fiscal 2005 data are still outstanding (see Table II).

For 2004, the average total elapsed time for clearance of original PMA applications was 290 days, compared with an average of 357 days the previous year. Average total FDA review time remained constant at 271 days in each year (see Table III).

For clearance of premarket notification (510(k)) applications, the average total elapsed time in fiscal 2005 was 69 days, compared with 92 days in fiscal 2004. Average total FDA review time on 510(k)s was 49 days in fiscal 2005, compared with 64 days the prior year (see Table IV).

During fiscal 2005, ODE received 240 510(k) submissions that were reviewed by third-party organizations under the accredited persons provisions of the Federal Food, Drug, and Cosmetic Act. For these submissions, the average clearance time from receipt to notification of approval to the 510(k) holder was 30 days in fiscal 2005—five days faster than reported in fiscal 2004. The ODE report states that CDRH is continuing to implement procedures to improve the quality and consistency of third-party reviews, and to facilitate timely CDRH action on such submissions.

In outlining its new initiatives in fiscal 2005, ODE reports that it conducted a pilot program to assess the quality of premarket reviews. Additionally, the report notes a major shift in the program related to postapproval studies ordered as conditions of approval for PMAs. Previously the responsibility of ODE, much of the work on these studies for novel or first-of-a-kind PMAs was transferred to the Office of Surveillance and Biometrics beginning on January 1, 2005.

ODE reports that it continues to pursue development of new information technology systems for improved tracking and monitoring of submissions. Additionally, ODE is active in the review of many combination device-drug and device-biologic products. For these reviews, the office is working with the Office of Combination Products, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research. In fiscal 2005, ODE reviewed 20 requests for designation—13 for device-drug combinations and seven for device-biologic combinations.

The 76-page ODE report highlights some of the innovative devices that were approved during the period covered by the report. Also included are reports from ODE divisions, guidance documents issued, staff awards and achievements, an overview of departmental organization, and a staff directory.

The full report is available at www.fda.gov/cdrh/annual/fy2005/ode.

© 2006 Canon Communications LLC

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