WASHINGTON -- Medical devices have been the most trouble-free of biotechnology's products; they have sailed smoothly through U.S. Food and Drug Administration review. But that situation is changing. These genetically engineered materials and technologies for treating and diagnosing disease are getting more complex. At the same time, Congress and the public are increasingly concerned that FDA is not being tough enough and that technology is inflating health care costs.

Last month, FDA and the State of Maryland hosted the International Biotechnology Conference on Applications to Medical Devices and Perspectives for Future Development. At this meeting, the first of its kind, FDA leaders applauded biotechnology companies for the more than 350 devices, primarily genetically engineered diagnostic tests, that have passed muster at FDA in the last decade.

And there's no end in sight. The integration of diagnostics, drugs, and devices is one of bio-technology's more promising applications, says Ralph Christoffersen, vice...

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