Description
Thisguideis intended to clarify section 812.7 of 21 CFR Part 812, the regulations providing procedures for investigational device exemptions (OMB CONTROL NUMBER 0910- 0078). This section prohibits the promotion or test marketing of investigational medical devices.
Scope & Applicability
Product Classes
2Can vary in design and intended use for minimal risk determination.
notices of availability and recruitment for study subjects
Stakeholders
5Institutional Review Board providing study approvals
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Entity responsible for submitting applications under section 524B
Governs top dose in clinical studies
Individuals responsible for monitoring and reporting protocol deviations
Related CFR Sections (5)
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
- 21CFR56.111§ 56.111 Criteria for IRB approval of research.
(a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:Read full regulation →
- 21CFR50.25§ 50.25 Elements of informed consent.
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →
- 21CFR50.20§ 50.20 General requirements for informed consent.
Except as provided in §§ 50.22 , 50.23 , and 50.24 , no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An invesRead full regulation →
- 21CFR812.7§ 812.7 Prohibition of promotion and other practices.
A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:Read full regulation →
Related Warning Letters (9)
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-03-12
Investigational Review Board (IRB)
Nobles Medical Technology II, Inc.
- 2023-06-06
Investigational Device Exemptions (Clinical Investigator)
Mobeen Mazhar, M.D.
- 2023-04-04
CGMP/QSR/Medical Devices/Adulterated
Synovo Production, Inc.
- 2020-04-07
Investigational Device Exemptions (Clinical Investigator)
Kennedy, Philip R.
See Also (8)
- Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff (Status: Final)
- Investigational Device Exemption (IDE) Guidance for Retinal Prostheses: Guidance for Industry and FDA Staff (Status: Final)
- Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs (Status: Draft)
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy: Developing Drug and Biological Products in Oncology (Status: Draft)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- Pharmacogenomic Data Submissions: Guidance for Industry (Status: Final)