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OCD FY2004: Opening Remarks from the Center Director

Dear Reader,

I’m pleased to issue the annual report for FDA’s Center for Devices and Radiological Health covering Fiscal Year 2004. This was my first full year as Center Director, and it’s given me a deep appreciation of the enormous responsibilities that go with the job. More importantly, I’ve gained an even deeper appreciation of the key qualities that make this Center outstanding: the dedication and drive of the people who work here.

It was largely those qualities that enabled us to meet the premarket MDUFMA milestones. To be sure, what you’ll read in this report are tables and charts that summarize the number of submissions received, the number approved, found SE’d, or NSE’d. But what you won’t see—because we lack the tools to capture and showcase this information—is the espirit de corps and teamwork that made it possible to achieve these milestones. Let me relate just one example. I recall the pressure the Center faced at the end of September to meet the October 1 deadline for taking action on the Supplement Validation Submissions submitted by single use device reprocessors. It was well past the traditional quitting time, but I saw people working into the evening hours to complete their reviews, making calls to their lab counterparts to confirm facts or checking with postmarket colleagues to get their input. As I watched this pace continue unabated into the weekend, it was clear to me that these folks were motivated by a strong sense of responsibility and a commitment to public health. And as I’ve seen all year, that spirit is shared all across the Center.

Another key that led to a very successful FY 04 was the fact that staff reached across divisions and offices to accomplish their work. Review teams included premarket and postmarket members. Numerous meetings, countless emails back and forth, and creation of e-rooms were all vehicles used to discuss settle points of disagreement, and develop Center consensus. This spirit of working together is exemplified in the cooperative pilot project between our postmarket epidemiologists and our PMA reviewers, now in its second year. Over the course of this year, epidemiologists have been working side by side with premarket application reviewers in all aspects of the review process—developing postmarket follow-up plans, designing post-approval studies, and following and monitoring the progress of already initiated PMA post-approval studies.

In keeping with the FDA-wide emphasis on risk-based regulation, this year we began using criteria that allowed us to focus our limited field resources on inspecting medical devices and manufacturers that present the greatest risk to public health. We made a similar effort in our bioresearch monitoring (BIMO) program, where we began performing BIMO inspections of clinical trials involving pediatric and physically challenged patients during the research phase of an investigational device, rather than after submission of a PMA. This early intervention helps prevent improper research from harming patients and interfering with the advancement of medical technology.

It’s important to remember that the second “M” in MDUFMA stands for “Modernization,” which means taking a serious look at our infrastructure. User fees allowed us to begin doing that, giving us the opportunity to make a deposit—albeit a small one—into updating our IT systems. For example, we deployed the initial version of a premarket review tracking system that will help us manage submissions, and we launched a pilot program that will enable manufacturers to complete a 510(k) original submission electronically. This is the kind of investment of resources that won’t necessarily reap dividends in the current fiscal year, but will begin paying off in future years. Without MDUFMA funds, we wouldn’t have been able to launch these projects.

On the postmarket front, we expanded the east coast and mid-west regional coverage of MedSun, our medical facility adverse event reporting system, by recruiting 180 new facilities, bringing the national number of reporting hospitals to 299. We also launched a pilot project called “LabSun,” and began collecting very useful pathology and in vitro diagnostics test reports from laboratories in the reporting hospitals.

We completed a 2-year review of CDRH’s Radiological Health Program and concluded that unnecessary population exposure to radiation comes largely from medical sources, and that the problem stems mainly from how medical radiation equipment is used, rather than equipment-related problems. To better address these findings, we have refocused our limited radiological health resources towards user and public education.

Science remains a priority for the Center. One example of how our scientists help move technology from bench to bedside can be found in the area of computer-aided diagnosis. Our scientists played a pivotal role in the approval of the first computer-aided diagnosis (CAD) system for detecting lung nodules on CT scans, one of the most significant medical devices approved this year. Anticipating this cutting-edge technology, they worked on developing the statistical methodology needed to demonstrate the effectiveness of the device, which facilitated its evaluation and approval.

Finally, we’re playing an important part in the FDA’s efforts to deal with national security. Our emergency response plan was updated; we have in place a process to identify and manage medical device shortages during public health emergencies; our scientists, working with FAA, studied the effect of metal detectors on medical devices; and for the first time, an anthrax test is available for use in state and private laboratories.

What I’ve provided here is just a brief overview of what CDRH has been doing over the past year. I encourage you to read the full report to get a more complete picture of what we’ve accomplished. I’m proud of those accomplishments, and grateful to everyone in CDRH for helping to make them possible.

Daniel G. Schultz sig


Daniel G. Schultz, M.D.
Director, Center for Devices and Radiological Health