FDA to Present on Medical Device User Fee & Modernization Act at Upcoming OEM Event.

Business Editors & Medical Writers

MD&M West 2003

LOS ANGELES--(BUSINESS WIRE)--Jan. 14, 2003

In an attempt to expedite market approval of medical devices, President George W. Bush signed into law a bill establishing the assessment of user fees for medical device manufacturers. The new law, named the Medical Device User Fee & Modernization Act of 2002 (MDUFMA), was developed to improve the FDA's ability to provide access to safe and effective medical devices. The user fees, paid by medical device makers seeking premarket approval, will help advance the device approval process, reduce time to market and allow consumers earlier access to new treatments and technologies. Furthermore, the FDA has broadened its review process by allowing manufacturers to utilize third parties to conduct their FDA required inspections.

At the upcoming Medical Design & Manufacturing (MD&M) West conference, held at the Anaheim Convention Center, February 19-21, manufacturers interested in learning how this bill will affect their companies are urged to attend a session lead by Federal Drug Administration representative William M. Sutton, consumer safety officer from the Center for Devices and Radiological Health (CDRH).

"When the President signed the Medical Device User Fee and Modernization Act in October, he provided the FDA with important new responsibilities, resources, and challenges," said Sutton. "Our session at MD&M West will present an overview of MDUFMA, which includes a summary that is intended to describe three key provisions of the new law: 1) user fees for pre-market reviews; 2) establishment inspections by accredited third parties; and 3) new regulatory requirement for reprocessed single use devices."

In addition, Larry Spears, Director of Office of Compliance (OC) will co-present the session providing an update on enforcement activity and an overview on CDRH points of focus for 2003.

The four-day, multi-track conference program will cover a variety of sessions such as Fundamentals of Medical Plastics Selection and Evaluation, Practical Software Validation, and Medical Packaging Design. In addition, manufacturers will be attracted to the wall-to-wall design, manufacturing, and packaging event featuring five events: MD&M West, PLASTEC West Pavilion, WestPack, Pacific Design & Manufacturing and Electronics West.

For more information about the MD&M West conference program and exposition, please visit the Web site at www.mdmwest.com. Produced and managed by CANON COMMUNICATIONS LLC, the Anaheim event is part of the company's worldwide family of trade shows. Information on all of CANON'S shows can be found at www.canontradeshows.com or by calling 310/445-4200.