> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Final Guide on IVDs in Oncology Trials
- URL: https://www.fdaweb.com/final-guide-on-ivds-in-oncology-trials/
- Published: 2019-10-10T12:00:00.000Z
- Updated: 2026-09-15T01:55:35.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145220

*Federal Register* notice: FDA has made available a final guidance entitled “Investigational *In Vitro* Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.” The document describes an optional streamlined submission process to determine whether use of an investigational *in vitro* diagnostic in an oncology clinical trial is considered significant risk, nonsignificant risk, or exempt from IDE requirements. Under the process, sponsors submit all information about an oncology trial (including information about the *in vitro* diagnostic) to the IND. As part of IND review, CDER or CBER will work with CDRH to determine if the *in vitro* diagnostic is significant risk, nonsignificant risk, or exempt. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-10-10/pdf/2019-22117.pdf?ref=fdaweb.com).