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# Draft Guide on IVDs in Oncology Trials
- URL: https://www.fdaweb.com/draft-guide-on-ivds-in-oncology-trials/
- Published: 2018-04-16T12:00:00.000Z
- Updated: 2026-09-14T23:59:13.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5141224

FDA has released a [draft guidance](https://www.fda.gov/MedicalDevices/NewsEvents/News/default.htm?ref=fdaweb.com) for industry entitled “Investigational *In Vitro* Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.” The document, which was developed by the agency’s Oncology Center of Excellence, CDER, CBER and CDRH. It describes an optional streamlined submission process for determining whether use of an investigational *in vitro* diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk (SR), nonsignificant risk (NSR), or exempt.

“If found to be SR, such a trial may require approval of an investigational device exemption (IDE) in addition to an investigational new drug application (IND),” the guidance says. “Regardless of whether a study involving an investigational IVD is determined to be SR or NSR, it must follow the abbreviated requirements outlined in 21 CFR 812.2(b), including generating and retaining data that demonstrate analytical validation of the investigational IVD. Sponsors can contact CDRH directly with questions relating to analytical validation of the investigational IVD.”