New Resources: Surrogate Samples Education


Upon creation of the Surrogate Sample Framework, MDIC’s working group developed a comprehensive set of educational materials to assist with shared terminology and principles for the acceptable use of surrogate samples between FDA reviewers and IVD test developers.

The Harmonized Education materials developed by the MDIC Surrogate Samples working group will be presented at the AACC (American Association for Clinical Chemistry) meeting.


Surrogate Samples Harmonized Education To be released July 30, 2018

Surrogate Samples, when properly used, decrease the time needed for analytical testing and reduce costs associated with in vitro diagnostic (IVD) test development and regulatory submission. The Surrogate Sample Framework was released in September 2017 to support innovation as well as provide a predictable path when using surrogate samples as part of an IVD regulatory submission.

The Surrogate Sample Framework is available for download here:

Surrogate Sample Framework

Since its release, the Framework has been accepted by the Clinical and Laboratory Standards Institute into its process to become an international standard; EP:39 Surrogate Sample Framework is expected publication of the standard is October 2020.

MDIC Surrogate Sample Harmonized Education to be presented at AACC Annual Meeting.

After completing the Surrogate Sample Framework, the working group set out to develop a comprehensive set of educational materials so that FDA reviewers and IVD test developers share terminology and principles for the acceptable use of surrogate samples.

The Harmonized Education materials developed by the MDIC Surrogate Samples working group will be presented at the AACC (American Association for Clinical Chemistry) meeting. The Scientific Session titled Harmonized Education: Use of Surrogate Samples in IVD Development and Regulatory submission will be held on July 30, 12:30 – 2:00 pm. Speakers include:

  • Carolyn Hiller, MBA, MDIC Program Director, Clinical Diagnostics
  • April Veoukas, JD, Director of Regulatory Affairs | Abbott | MDIC Surrogate Samples Working Group Chair
  • Marina Kondratovich, PhD, Associate Director for Clinical Studies | FDA | CDRH | OIR, MDIC Surrogate Sample Working Group Member

Additional information on the conference can be found by visiting AACC’s Conference Web page

The Scientific Session can be viewed here.

Check back at the end of the month to view the Harmonized Education materials that will be available on the MDIC website by July 30, 2018.