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FDA holds educational forum

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 3, 2007

Small device businesses, entrepreneurs, and start-ups can gain knowledge about FDA requirements and compliance at a public workshop to be held this October in Dallas. In an August 21 notice, the FDA announced a workshop co-sponsored by the FDA Medical Device Industry Coalition, titled "Medical Devices 101: An Educational Forum."

The same forum was presented in February 2007 and will offer an overview of FDA medical device requirements. The workshop is intended to help small device businesses to comply with the Medical Device Quality System Regulation. It will address:

• device classification
• establishment registration
• device listing
• pre-market notification and approval
• quality system regulation
• device labeling
• recalls
• medical device reporting
• post-market surveillance

The full-day workshop occurs October 26. Early registration ends on October 12 and registration will close when the workshop is filled. Click here for more information.

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