Description
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.
Scope & Applicability
Product Classes
3In vitro diagnostic device being evaluated in an oncology trial
codevelopment of an investigational IVD with an oncology investigational drug
IVD device clinical studies conducted on de-identified specimens
Stakeholders
3Governs top dose in clinical studies
The primary entity responsible for communicating with FDA in a codevelopment program
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
3Status where an IVD is exempt from IDE requirements
Risk classification for medical device clinical investigations.; A risk determination for a clinical study.
Risk classification for medical device clinical investigations.; A classification for medical device studies.; A risk determination for a clinical study.
Related CFR Sections (5)
- 21CFR812.62§ 812.62 IRB approval.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part.Read full regulation →
- 21CFR312.66§ 312.66 Assurance of IRB review.
An investigator shall assure that an IRB that complies with the requirements set forth in part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in thRead full regulation →
- 21CFR312.23§ 312.23 IND content and format.
(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →
- 21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
- 21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.Read full regulation →
Related Warning Letters (6)
- 2025-09-23
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-01-09
Clinical Investigator
Jeffrey W. Taub, M.D./Children's Hospital of Michigan
- 2023-09-29
Clinical Investigator
Luis Javier Pena-Hernandez, M.D., FCCP
- 2022-03-15
Clinical Investigator (CI)
Sabine S. Hazan, M.D.
- 2020-03-10
Clinical Investigator
James R. Corbett, M.D.
See Also (8)
- Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff (Status: Final)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical Investigators (Status: Final)
- Using a Centralized IRB Review Process in Multicenter Clinical Trials: Guidance for Industry (Status: Final)
- Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial Sponsors (Status: Final)
- Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBs (Status: Final)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)
- Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)