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
