Who should read this message?
This is message is for anyone conducting human participant research involving drugs or devices.
What is happening?
The IRB has updated the following materials regarding the use of drugs and devices in research:
| Status | Page / Resource | What it Covers |
|---|---|---|
| *New* | Worksheet: FDA IND Exemption Worksheet | FDA requirements for drugs and IND submissions |
| Updated | Worksheet: Devices | Updated worksheet and guidance on research involving devices |
| Updated | Website Guidance: Investigational New Drugs and Biologics | Updated research guidance for INDs and biologics |
| Updated | Website Guidance: Investigational Devices | Updated research guidance for medical devices |
Summary of Changes
Please note: The FDA has not changed its guidance on drugs and devices. The following IRB updates simply provide more detailed information about existing regulations.
| Section | Resource | Change Summary |
|---|---|---|
| Worksheets | Investigational Drug & Investigational Device Worksheets (IND/IDE determination tools) | These worksheets are designed to help researchers determine if:
The worksheets have been updated to:
|
| Website Guidance – Drugs | Investigational New Drug and Biologics Guidance | Added guidance on when an IND is required or not required, OTC monographs, active ingredient assessment, differences between legally marketed and commercially available drugs, responsibility for IND determinations, and FDA contact information. |
| Website Guidance – Devices | Investigational Device Guidance | Added guidance on indirect safety/effectiveness evaluations, general wellness devices, differences between legally marketed and commercially available devices, responsibility for IDE determinations, and FDA contact information. |
Action Items for Researchers Conducting Studies with Drugs and Devices
✅ Do:
- Familiarize yourself with the updated webpages on drugs and devices.
- Moving forward, use the new IND and IDE worksheets when submitting new studies to the IRB.
🚫 Dont:
Modify your approved studies to use the new worksheets.
Change your already-submitted new studies to use the new worksheets.