ANSI - American National Standards Institute
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AAMI and FDA Announce Joint Conference on Medical Device Standards


New York, Jan 14, 2003

The Association for the Advancement of Medical Instrumentation (AAMI) and the U.S. Food & Drug Administration (FDA) have announced that their 13th Annual AAMI/FDA International Conference on Medical Device Standards & Regulation will be held March 11-12, 2003 in Washington, D.C.

AAMI, a non-profit organization of users and manufacturers of medical instrumentation and technology, is also an ANSI-accredited standards developer. The organization develops standards and provides information concerning the safe and effective use of medical devices. Their joint conference with the FDA is targeted at individuals who are responsible for tracking and monitoring compliance with medical device standards and regulations for their organizations.

There are seven sessions scheduled for the conference. Speakers at the AAMI/FDA conference will include FDA and European regulatory and conformity assessment officials and experts from multi-national companies concerned with medical device standards.

Topics will include the implications of the Medical Device User Fee and Modernization Act of 2002, passed in October, which addresses user fees for pre-market reviews of new devices, inspections of manufacturers by accredited third parties and requirements for reprocessed single-use devices. A recent revision of ISO 13485, Quality systems-Medical devices-Particular requirements for the application of ISO 9001, concerning the regulatory needs of device manufacturers, will be explained by the FDA and industry representatives, and speakers will also discuss medical device risk management through ISO 14971, Medical devices - Risk management - Application of risk management to medical devices.

A luncheon session on the 11th will feature David Feigal, Jr., M.D., director of the FDA’s Center for Devices & Radiological Health and a member of the ANSI Board of Directors. Dr. Geetha Rao of John Cabot International will speak at a luncheon on the 12th and will discuss the legal risks and implications of the standards development process.

Individuals interested in registering for the conference should call AAMI’s customer service center at 800.332.2264 ext 217. For further information on program content for the AAMI/FDA International Conference on Medical Device Standards & Regulation, contact Deborah Reuter, director of government programs for AAMI, at 703.525.4890 ext 256 or dreuter@aami.org.

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