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Age Suitability None Specified
Category Talks & Lectures

Changes to the 510(k) System - Impact on Innovation, Investment, and Business Development: One and a half day In-person Seminar

Thursday, Nov 7, 2013 8:30a
Grand Hyatt San Francisco San Francisco, CA

Course Description:
This interactive one and a half day seminar will cover the basics and advanced knowledge of the 510(k) program. It will provide insights on what FDA looks for in 510(k) submissions and common mistakes companies make in drafting 510(k)s. The course will include observations and commentary on CDRH’s new proposals for the 510(k) program such as:

Draft Guidance for Industry and Food and Drug Administration Staff.
The 510(k) Program: Evaluating Substantial Equivalence in Premarket
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Location & Nearby Info
Grand Hyatt San Francisco
345 Stockton St.
San Francisco, CA 94108
(415) 398-1234
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