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Lightening Workshop: Exploring the Intended Use Statement's Impact on Regulatory and Marketing Strategies

Eri Hirumi  (Regulatory Affairs Specialist, Microvention)

Location: Biomed Room 1

Date: Thursday, September 17

Time: 3:00 pm - 4:30 pm

Track: Track C: Surviving the Changing Regulatory Environment & Rising Costs

Vault Recording: TBD

A key challenge for obtaining market authorization for any new Medical Device is the crafting of the intended use statement. It must be similar enough to other products already available to qualify for substantial equivalence evaluation but provide unique features to allow for innovative marketing statements. Balancing the needs of these two polar concepts is a critical skill for the development of a novel medical device.

This workshop will:
  • Explore impacts of the intended use statement on reimbursement, regulatory and market strategy, including label design
  • Discuss product and process validation plans
  • Provide opportunities to practice developing intended use statements to understand the impacts upon getting products to market