Surrogate Samples

Needs and Opportunities (Problem/Challenge):

  • Difficulty obtaining clinical specimens delays the development of innovative and improved diagnostics impacting patient access.
  • A predictable path for surrogate sample use does not exist.

Vision (Solutions):
Establish a foundation for the use of surrogate samples to support IVD product development and the regulatory process.

Value to Stakeholders:

  • Patients:  Expedited access to medical device technologies
  • Industry:
    • Decrease time for analytical testing by using surrogate samples
    • Reduce costs and time of sample collection for development and submission.
  • FDA/CDRH:
    • Support CDRH’s mission to maintain US leadership in medical device innovation and expedited patient access to new technologies
    • Provide predictable path for use of surrogate samples