IVD Studies are Different: A Strategic Approach to Regulatory Compliance

Insights in action from the IVD experts

As diagnostic manufacturers begin the commercialization process of their assay, a crucial first step is developing a comprehensive regulatory strategy that will inform program planning and study design. This whitepaper seeks to highlight key considerations during regulatory strategy development that will help ensure an IVD or CDx product successfully reaches the market.

Download our whitepaper to learn more about:

  • How IVD studies are unique, and the steps required for effective regulatory strategy and study design
  • Distinctions between regional IVD regulatory requirements in the U.S. and global markets
  • Key characteristics of IVD assays that all sponsors must address in regulatory program planning
  • An overview of study types and evidence requirements — and their impact on regulatory requirements
  • Considerations for Companion Diagnostics (CDx), POC and home-use IVDs

Get the information you need to start your IVD study planning with confidence along with proven strategies for a successful FDA submission.