> ## 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.

# Draft Guide on Streamlined Approach for Oncology IVDs
- URL: https://www.fdaweb.com/draft-guide-on-streamlined-approach-for-oncology-ivds/
- Published: 2018-04-17T12:00:00.000Z
- Updated: 2026-09-14T23:59:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141234

*Federal Register* notice: FDA has made available a draft guidance entitled “Investigational *In Vitro* Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.”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 an investigational *in vitro* diagnostic in an oncology clinical trial under an IND (an oncology co-development program) is a significant risk. In the streamlined process, all information about the oncology trial (including information about the investigational *in vitro* diagnostic) is submitted to the IND. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07812.pdf?ref=fdaweb.com).