Updated Drug and Device Guidance and Worksheets

By UCSF HRPP on

 

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:

New:
Updated:

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. 

Summary of Changes:

Drug and Device Worksheets:

These worksheets are designed to help researchers determine if:

  • A study drug qualifies for an Investigational New Drug (IND) exemption
  • A study device qualifies for an Investigational New Device (IDE) exemption

The worksheets have been updated to:

  • Ask additional questions to better help study teams make and document their IND/IDE determination, and
  • Provide more resources and guidance about how to correctly fill out the worksheet.

 IRB Website:

Guidance on the following topics has been added to the drugs and devices website pages: 

Drugs:

  • Examples of when an IND is needed or may not be needed
  • Over the counter monographs
  • Assessment of active ingredients
  • Differences between legally marketed and commercially available drugs
  • Who is responsible for IND determinations
  • FDA contact information

Devices:

  • Indirect evaluations of safety or effectiveness 
  • General wellness devices 
  • Differences between legally marketed and commercially available devices
  • Who is responsible for IDE determinations
  • 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. 
Do Not:

  • Modify your approved studies to use the new worksheets. 

  • Change your already-submitted new studies to use the new worksheets.