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.
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
- Decrease time for analytical testing by using surrogate samples
- Reduce costs and time of sample collection for development and submission.
- 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