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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

Evaluating_PreMarket_Pathways_for_the_US_Market__510k_De_Novo_and_PMA_.pdf