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GUIDANCE DOCUMENT

Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry October 2019

Final
Docket Number:
FDA-2018-D-0944
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to describe 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 from investigational device exemption (IDE) requirements. If the IVD in the trial is determined to be SR in the streamlined process, the sponsor may need to submit an IDE to the appropriate center (Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER)) in addition to submitting an investigational new drug application (IND) to the appropriate center (Center for Drug Evaluation and Research (CDER) or CBER). FDA encourages sponsors to use the streamlined process described in this guidance when possible to reduce administrative burden on sponsors and FDA and to maintain the current level of regulatory review.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-0944.