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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.

Evaluating Pre-Market Pathways for the US Market - 510(k), De Novo, and PMA

Kim Walker (Global Regulatory, Quality, & Clinical Consultant, Kim Walker Consulting)

Location: 210D

Date: Thursday, February 7

Time: 10:15am - 11:00am

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

Developing a strategic medical device pre-market plan for new devices can impact how quickly your product will get to the US market.

Topics covered include:
  • The benefits and challenges of different US pre-market submission pathways
  • FDA perspective on predicate device criteria — examining predicate device selection techniques
  • Understanding checklists and timelines for FDA refuse-to-accept policy

Presentation File