Originally Published MX March/April 2003

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

The device user fee act imposes new rules on both OEMs and reprocessors—and leaves a lot of details to be worked out.

Jeffrey L. Wendt

Issues related to medical device reprocessing were settled somewhat when the Medical Device User Fee and Modernization Act of 2002 became law last autumn.¹ Aspects of the legislation had been discussed and debated within the medical technology industry for years. The discussion will continue. The final law, though groundbreaking, leaves device industry leaders wondering about obligations imposed by the act on reprocessors and still seeking complete resolution of intellectual property issues surrounding patents and trademarks.