The relevance and reliability of the data are dependent on the specific regulatory decision. While evaluating the potential utility of real-world data (RWD) for generating real-world evidence (RWE) in regulatory decision-making, the FDA considers the following elements:

  • •   Data availability
  • •   Linkages
  • •   Timeliness
  • •   Generalizability of data
  • •   Data accrual
  • •   Data quality and integrity

Furthermore, studies utilizing RWD should undergo a thorough assessment before or during analysis to ensure the data's fitness for the intended purpose. The FDA acknowledges that certain regulatory decisions may lack sufficient support from RWE for various reasons. Therefore, the FDA recommends the following key points:

  • •   Whether to include randomization, concurrent, or historical controls
  • •   The choice of performance goals and objective performance criteria
  • •   Type I and Type II error control
  • •   Data gathering or dependence on existing data
  • •   Bias mitigation strategies
  • •   Precision of outcome measures and other data elements, as applicable
  • •   All other known factors pertinent to the interpretation of the study results




Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices