FDA Regulated Research

For those research protocols subject to the FDA regulations, more information or procedures may be required in the IRB protocol submission to meet FDA-specific requirements. The FDA regulations are delineated on the Federal Regulations and Policies page.

IRB submission forms for the use of Drugs, Food, Biologics, Dietary Supplements and Medical Devices can be found on the IRB forms page under Supplemental Forms For Studies Using Medical Devices and Drugs.

The following are commonly used FDA guidance documents and resources for IRBs, Clinical Investigators, and Sponsors.

Informed Consent:

• Informed Consent, Guidance for IRBs, Clinical Investigators, and Sponsors

Investigator Responsibilities:

• Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
• Off-Label and Investigational Use of Marketed Drugs, Biologics, and Medical Devices
• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
• Certificates of Confidentiality

IRB Responsibilities:

• IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.pdf
• Payment and Reimbursement to Research Subjects

Medical Devices:

• How to Determine if Your Product is a Medical Device
• General Wellness: Policy for Low Risk Devices
• Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies
• IDE Approval Process
• Resources to find the current FDA status of the device to be used in research protocol procedures:
• PMA Approved
• 510(k) Cleared
• 510(k) Exempt
• Registration and Listing

Databases for Approvals and Clearances

• Frequently Asked Questions About Medical Devices.pdf
• Significant Risk and Nonsignificant Risk Medical Device Studies.pdf
• Off-Label and Investigational Use of Marketed Drugs, Biologics, and Medical Devices
• Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of the Study Subject 
• Guidances with Digital Health Content

Drugs, Biologics, Foods, and/or Dietary supplements:

• Guidance for Clinical Investigators, Sponsors, and IRBs Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND

• Determining Whether Human Research Studies Can Be Conducted Without an IND
• For approved drugs, see Drugs at FDA for package insert
• To find the drug label for a FDA approved drug, see the FDA Online Label Repository

Good Clinical Practice Guidelines:

If the study meets the NIH definition of a Clinical Trial (regardless of funding), the study must comply with ICH E6 Good Clinical Practice (GCP)

Monitoring:

Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring

To find additional FDA Guidance Documents, please search here.

To search for FDA Acronyms and Abbreviations, please search here.