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The Essentials of Medical Device Regulations: A Primer for Manufacturers and Suppliers

Date:   Wednesday, July 13-14, 2010
Time:   Day long

Hilton San Francisco Financial District
750 Kearny Street
San Francisco, CA 94108


Sponsor:   Medical Technology Learning Institute
Event details:  

This two-day program, co-sponsored with FDA’s San Francisco District and the Center for Devices and Radiological Health, is designed to teach small manufacturers and those new to the industry the essentials of medical device regulation, the scope of FDA authority, premarket submissions procedures, the quality system regulations, postmarket requirements, and sources of help and information. The program also includes an overview of medical technology reimbursement and the shifting ethical and legal guidelines for the sales and marketing of medical technology. Program faculty includes key representatives from FDA’s San Francisco District Office, the Division of Small Manufacturers, International, and Consumer Affairs, the CDRH Office of Compliance, and from industry. Ample time is available for general discussion and for informal conversation with FDA speakers.

Full Agenda



Sliding Scale


Additional information and/or registration:   Additional Information and Registration

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