FDA Regulatory Support Program

The UT Regulatory Support Program, part of the Human Research Protection Program (HRPP), offers comprehensive guidance and navigation support to investigators conducting human subjects research with investigational drugs, devices, and biologics.

Whether you are conducting a minimal risk investigation with an IDE-exempt device or pursuing a clinical drug trial under an IND, the Regulatory Support team is here to help researchers through every step of the process. We also work closely with the IRB committee and staff to support review of FDA-regulated research.

Topics we support include:

• Navigating regulatory requirements for investigational drugs, devices, and biologics
• Understanding sponsor-investigator responsibilities
• Preliminary assessment of whether an IND, IDE, or Abbreviated IDE is required
• IND/IDE application support
• Expanded access treatment requirements
• Emergency use of an unlicensed drug, device, or biologic
• FDA inspection preparation
• Requesting meetings with the FDA
• Device premarket process
• And more!

What is "FDA-regulated" research?

In the US, the Food and Drug Administration (FDA) maintains regulations for research involving drugs, devices, and biologics for investigational human use. A study is considered FDA regulated if it meets the FDA’s definition of a clinical investigation of a drug or device. The following circumstances qualify a study as a clinical investigation:

• Any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.
• Any experiment that involves a test article (i.e. medical device) and one or more human subjects to determine the safety or effectiveness of a device.

Not all FDA-regulated research requires submission of a drug or device application to the FDA. Different FDA requirements apply depending on the type of study (drug, device, biologic) and the specifics of the protocol. The UT HRPP oversees FDA-regulated research and helps ensure requirements are met before, during, and after IRB review.

Find details on the FDA’s research requirements and IRB considerations.

Investigational Drugs and Biologics

FDA regulations for investigational drugs apply to all uses of a drug or biologic in humans, other than a lawfully marketed drug or biologic administered during medical practice. Like medical devices, drugs are broadly defined depending on the type of product and its intended use.

UT Guidance: Investigational Drugs and Biologics (Coming soon!)

Investigational Devices

FDA regulations apply to research uses of investigational medical devices. “Investigational” means the device is the object of an inquiry regarding its safety and/or effectiveness. Medical devices are a broad category that includes many different formats, from implanted articles to diagnostic software.

UT Guidance: Investigational Devices (PDF)

Humanitarian Use Devices (HUDs)

A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects no more than 8,000 individuals in the United States per year. It is a pathway for obtaining legal marketing status of devices for conditions that are too rare to conduct robust clinical trials in order to establish efficacy of a device. A HUD has a Humanitarian Device Exemption (HDE), a type of approved marketing application. HUDs must have demonstrated a reasonable assurance of safety to be approved for marketing, but their effectiveness is subject to different standards.

Although HUDs are not research devices, FDA regulations require local IRB review before a HUD may be administered at a given facility.

UT Guidance: HUDs (Coming soon!)

Expanded Access

Expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to gain access to an unapproved drug, biologic, or medical device for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. It encompasses treatment uses in emergency and non-emergency situations, as well as for individuals, small groups/intermediate populations, and widespread use.

UT Guidance: Expanded Access – Drugs and Devices (Coming soon!)
UT Guidance: Expanded Access – Medical Devices (Coming soon!)

Emergency Use

Emergency use, a subtype of expanded access, refers to treatment-only use of an unapproved drug, biologic, or device in an emergency situation when there is no time to obtain prospective IRB approval of the treatment protocol or to go through the normal channels for approval of a single patient IND or IDE. An emergency IND or IDE is issued by the FDA for emergency use.

UT Guidance: Emergency Use (PDF)

FDA Contacts for Emergency Use

During normal business hours (8 am - 4:30 pm, Mon – Fri, excluding federal holidays), please use the contact information for each area below.

FDA Inspections

If you have been given notice that your study or lab will or might be inspected by the FDA, please immediately notify regsupport@austin.utexas.edu.

Regulatory Support staff are here to assist PIs and study teams with preparation and other support for FDA inspections.