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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

FDA’s Emphasis on Speed, Quality, & Innovation: What Does it Mean for You?

Daniel Schultz, MD (Principal, Medical Devices & Combination Products (Director, CDRH 2004 - 2009), Greenleaf Associates)

Location: 210D

Date: Tuesday, February 5

Time: 9:15am - 10:00am

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

The emphasis for FDA is now on flexible regulatory concepts applied across the total product life cycle. This session will focus on current FDA strategic priorities through 2020, including the numerous pilots designed to increase speed to market while maintaining focus and support of quality.

Topics covered include:
  • The FDA’s top areas of concern for innovation and quality
  • Updates on 510(k), De Novo, and other pre-market activities
  • Real world evidence
  • Benefit/risk and uncertainty

Presentation File