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Working with drugs, products, or devices regulated by the Food and Drug Administration
Many Indiana University investigators conduct research with drugs, biological products, and/or devices regulated by the Food and Drug Administration. IU’s Quality Improvement Office collaborates with the Indiana Clinical & Translational Sciences Institute to provide education and support for investigators holding an Investigational New Device or an Investigational Device Exemption.
When is submission of an Investigational New Device application required?
Most investigations of drugs or biological products require submission of an Investigational New Drug (IND) application to the FDA.
- If the study involves a drug used in humans in any way other than in the course of medical practice, an IND is required unless certain exemptions apply.
- Exemptions are some investigations of already approved drugs, some studies using diagnostic biological products and in vitro drug tests, and some bioavailability or bioequivalence studies.
- For additional background, see the FDA’s regulations . A study that is exempt from the IND requirement must still comply with FDA requirements for IRB review and informed consent.
When is an Investigational Device Exemption application required?
When the principal intent of the medical device (or other product regulated as a device) is to develop information about the product’s safety or efficacy, submission of an IDE application is ordinarily required. In certain circumstances, however, the FDA does not require an IDE.
- Investigations of devices fall into one of three categories:
- Exempt from IDE requirements
- Studies of nonsignificant risk devices subject to abbreviated IDE requirements
- Significant risk devices subject to full IDE requirements.
- A study that is exempt from the IDE requirement must comply with FDA requirements for IRB review (same link as above) and informed consent (same link as above).
The summaries linked below will guide you in determining responsibilities.
- Sponsor-investigator responsibilities for INDs v03/09/16 (Accessible 04/12/21)
- Sponsor-investigator responsibilities for IDEs v01/13/16 (Accessible 04/12/21)
FDA forms, regulations, and guidance documents
The links below provide you with information regarding INDs or IDEs. Some of topics are very specific to therapeutic areas, and others are general.
- Center for Drug Evaluation and Research Guidance Documents
- Center for Biologics Evaluation and Research Guidance Documents
- Device Advice: Comprehensive Regulatory Assistance
- Investigational New Drug (IND) Forms & Submission Requirements
- All Clinical Trials FDA Guidance Documents
- CFR – Code of Federal Regulations Title 21 Search page
- IDE Regulations
- IND Regulations
- Sign up to receive emails about important information and updates directly from the FDA
IU's Quality Improvement Office recommends the following to stay abreast of important FDA related information
Indiana CTSI Project Manager - Regulatory Knowledge and Support
Quality Improvement Office