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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
This Copy Was Generated On: June 3, 2026
FDA guidance – General, Drug and Biologicals, Medical Devices, and FDA operations
IRBMED
| Approval Date:
November 2, 2020 3:15 pm
The term “test article” is found in the FDA regulations on Protection of Human Subjects (21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products.
General
- Frequently Asked Questions
- Cooperative Research
- Non-local IRB Review
- Continuing Review After Study Approval
- Sponsor – Investigator – IRB Interrelationship
- Foreign Clinical Studies, Acceptance of
- Charging for Investigational Products
- Recruiting Study Subjects
- Payment to Research Subjects
- Screening Tests Prior to Study Enrollment
- Informed Consent, A Guide to
- Use of Investigational Products When Subjects Enter a Second Institution
- Exception from Informed Consent Requirements for Emergency Research
- “Off-Label” and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices
Drugs and Biologics
Medical Devices
- Frequently Asked Questions About Medical Devices
- Significant Risk and Nonsignificant Risk Medical Device Studies
- Clinical Decision Support Software
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (DRAFT 01/2025)
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Questions?
Contact us at [email protected] or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Ann Arbor, MI 48109-2800
A list of IRBMED staff is available at our website.
Edited By: [email protected]
Last Updated: April 29, 2026 10:00AM
See Also
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Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.