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U.S. Department of Health and Human Services

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OCD FY2000: Bringing new products to market

New Leadership . . .

In July 2000, the Center filled a key position when it welcomed Bernard E. Statland, M.D., Ph.D., as the new Director, Office of Device Evaluation (ODE). Dr. Statland is a board certified clinical pathologist and brings a wealth of experience to the Center’s premarket program. He leads an experienced management team that includes ODE Deputy Directors Philip Phillips, Kimber Richter, M.D., and—most recently—Daniel Schultz, M.D. Dr. Schultz directed ODE’s Division of Reproductive, Abdominal and Radiological Devices before his September 2000 selection as an ODE Deputy Director.

. . . and Continued Success

Our premarket review processes remained highly productive and timely during this period of management transition. We maintained—and, in some areas, even improved upon—last year’s near-record performance, allowing safe and effective devices to reach the market rapidly. For the fourth consecutive year, no premarket submissions were overdue at the year’s end.

  • Premarket Notification (510(k))
Most medical devices receive premarket review through the 510(k) process. In fiscal year 2000, we reviewed 4,397 510(k) submissions, slightly less than the 4,593 reviews completed last year. Our average review time (77 days) was the shortest in more than a decade. The average total elapsed time to clearance (which includes time while FDA review was "on hold" awaiting more information) remained stable at 102 days.
  • Premarket Approval
Premarket approval applications (PMAs) represent the highest level of regulatory scrutiny applied to medical devices. We approved 43 PMAs this year, compared to 39 approvals last year (not including HDE applications, discussed below). Average total elapsed time to PMA approval was 11.9 months, an improvement from last year’s average of 12.5 months, and a 54 percent reduction from the "peak" time of 25.9 months in fiscal year 1996. In addition, we approved 474 PMA supplements, the most in any year since 1991. The average total elapsed time for approval of PMA supplements was 4.0 months—comparable to last year’s average of 3.9 months, the most rapid since the early days of the PMA program.
  • Humanitarian Device Exemption (HDE)
HDE applications are similar in form and content to PMAs, but are exempt from the effectiveness requirements of PMAs. We approved 6 HDE applications this year, the same number as in Fiscal Year 1999. The average total elapsed time to approval increased from 163 days to 216 days, but our average review time (i.e., excluding time "on hold") was 112 days, similar to last year’s average of 113 days.
  • Investigational Device Exemption (IDE)
IDEs are the mechanism through which FDA assures that human subjects are protected in medical device clinical trials. We reviewed 320 original IDE submissions in Fiscal Year 2000, the second highest number of reviews completed in any year since the IDE program began. We also reviewed 4,335 IDE supplements this year, more than any prior year. Our average review time for original IDE submissions (28 days) was similar to last year’s average (27 days). Seventy-six percent of original IDEs were approved for clinical trials in their first 30-day cycle—a greater percentage than in any prior year. Our average review time for IDE supplements remained at last year’s level (20 days), which was the best in the history of the program.

Significant Advances in Patient Care

Underlying the program statistics are the products that we review. This year, we granted marketing approval or clearance to numerous medical breakthrough devices that will provide significant improvements in patient care. These devices reflect the increasing sophistication and complexity of medical technology. Examples include:

  • A robotic arm that enables a surgeon to perform laparoscopic gall bladder and reflux disease surgery while seated at a console with a computer and video monitor;
  • A digital mammography system for breast cancer screening in women. This new technology offers several potential advantages over film/screen mammography, including electronic storage and transfer, manipulation of image area, and large dynamic range;
  • A new type of fetal monitor that measures oxygen saturation in the baby’s blood as a sign of fetal health during labor and delivery;
  • A surgically implanted device intended to help adults with moderate to severe nerve hearing loss, as an alternative to traditional hearing aids;
  • A new type of artificial embolization device used to occlude blood flow to facilitate surgical treatment of cerebral arteriovenous malformations (AVM);
  • A cardiac catheter with technology that allows more rapid and accurate mapping of the inside of the heart to improve the technique of cardiac ablation for treating arrhythmia;
  • Diagnostic tests for detecting chronic alcohol abuse, to help triage patients with alcoholism and to monitor compliance with treatment programs;
  • A laser device for treatment of hyperopia, hyperopic astigmatism, and mixed astigmatism; and
  • A new type of surgical sealant used to seal air leaks in lungs following lung cancer surgery.

Improved Communication

Recent approvals, such as those listed above, are being communicated to the public through a new web page. This initiative recognizes the public’s rapidly growing use of the internet to obtain important health-related information. The new web page contains timely, consumer-oriented information about recently approved devices.

Greater Efficiency and Effectiveness

We continued efforts to increase the efficiency of premarket reviews and to focus our review resources on devices that present the most risk. For example:

  • In March 2000, we published a final rule down classifying 28 well-understood, pre-1976 device types from Class III (premarket approval) into Class II (special controls). Had we not initiated this action, these devices—such as denture repair kits—eventually would have required premarket approval even though other, less costly controls are sufficient.
  • In April and July 2000, we published final rules for four pre-1976 Class III devices, so that they now require premarket approval.
  • In August 2000, we down-reclassified, from Class III to Class II, extracorporeal shock wave lithotripters used for fragmentation of kidney and ureteral stones. This action is noteworthy not only because it exemplifies our efforts to reduce regulatory burdens—consistent with the least burdensome provisions of the FDA Modernization Act of 1997 (FDAMA)—but also because it represents our first use of FDAMA’s 6-year data provision (Section 216). The 6-year data provision allows reclassifications and certain other actions to be based on data contained in PMAs that have been approved for at least 6 years. PMA data provided part of the basis for this action. (This use of the 6-year provision also led to the issuance of FDA guidance on how the provision will be used in the future--see additional information on the implementation of FDAMA elsewhere in this Annual Report).

New Challenges

Even as we strive to keep pace with a diverse and dynamic industry and to make improvements to our review processes, new challenges arise. One such challenge stems from the Clinical Laboratory Improvements Amendments of 1988 (CLIA). In January 2000, the responsibility for categorization of commercially marketed products under CLIA was transferred from the Centers for Disease Control and Prevention to FDA. This allowsmanufacturers to submit premarket applications for products and CLIA requests for complexity categorization of those products to one agency. This year, we issued draft guidance on the administrative procedures for CLIA categorization and took other steps to address this new responsibility. We also addressed premarket issues associated with preparations for Y2K, re-use of single use devices, global harmonization, and other challenges.