To determine whether or not FDA regulations apply to your study, consider the three questions below. Answering 'yes' to all three questions indicates FDA regulations do apply.
1. Is your study evaluating what the FDA considers to be a test article?
A test article is defined by the FDA as:
- Drugs or biologics: Any substance that is described by one of the following:
- Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease;
- Intended to affect the structure or any function of the body (not including food);
- A substance intended for use as a component of a medicine.
Note: Dietary supplements, foods, and other ingestibles are considered 'drugs' if they are utilized to diagnose, cure, treat, mitigate, or prevent a disease or condition.
- Devices: An instrument that can be described by one of the following:
- Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or other conditions;
- Intended to affect the structure or any function of the body.
Note: Some software, wearable technology, exercise devices, etc. may be classified as a medical device. Please refer to the FDA guidance on Digital Health Content for more information.
2. Are you conducting a clinical investigation?
A clinical investigation, as defined by the FDA, is "any experiment that involves a test article and one or more human subjects".
3. Does your activity (research) involve human subjects?
The FDA defines human subjects as "an individual who is, or becomes, a participant in research, either as a recipient of the test article or as a control".
Note: de-identified human biological specimens used in this type of study qualifies as a human subject.
If you answered 'yes' to all three of the above questions,
then your research is FDA-regulated.
FDA Guidance Documents
FDA Regulations
The Code of Federal Regulations (CFR) Title 21 CFR is specific to rules and regulations of the FDA. Regulations pertaining to human subjects research include:
- Protection of Human Subjects 21CFR§50
- Institutional Review Boards 21CFR§56
- Investigational New Drug 21CFR§312
- Biological Products 21CFR§600
- Investigational Device Exemptions: 21 CFR 812
- Premarket Approval of Medical Devices (includes HUDs): 21 CFR 814
- Medical Device Classification Procedures: 21 CFR 860
- Requirements for Device Registration and Listing: 21 CFR 807
- Electronic Records; Electronic Signatures: 21 CFR 11
- Financial Disclosure by Clinical Investigators: 21 CFR 54
- Quality System Regulation: 21 CFR 820
Drug Guidance
- IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.pdf
- Determining Whether Human Research Studies Can Be Conducted Without an IND
- Off-Label and Investigational Use of Marketed Drugs, Biologics, and Medical Devices
- Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of the Study Subject
- IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer.pdf
Device Guidance
- IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.pdf
- 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
- IVD Device Studies – FAQs.pdf
- Informed Consent for IVD Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
- Guidances with Digital Health Content
- Premarket Approval of Medical Devices (includes HUDs): 21 CFR 814
- Medical Device Classification Procedures: 21 CFR 860
- Requirements for Device Registration and Listing: 21 CFR 807
FDA References
Helpful Links
Regulatory language may be difficult to understand, especially for those who are new to reading these types of documents. However, it is mandatory that researchers and study teams understand the complex regulations surrounding IND/IDE trials. The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) site provides excellent guidance that many find accessible, and we recommend research teams start there.
- Regulatory Guidance for Academic Research of Drugs and Devices
- Investigational New Drug or Biologic Information and Decision Tree on the ReGARDD site
- Investigational Device Exemption Information and Decision Tree on the ReGARDD site