FDAnews
www.fdanews.com/articles/81094-fda-to-review-device-ad-requirements

FDA TO REVIEW DEVICE AD REQUIREMENTS

September 22, 2005

The FDA is considering whether device manufacturers must submit their promotional materials for review and whether they should face penalties for misleading or false materials. In November, the FDA will hold a two-day public meeting with patients, doctors, manufacturers and others to discuss possible changes to its marketing requirements for materials aimed at individuals, known as direct-to-consumer advertising.

Currently most medical devices are not subject to FDA promotional regulations, but that might change. "I would encourage device companies to take seriously the issues," said Deborah Wolf, a lawyer for FDA's device division.

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