{"id":561,"date":"2026-04-10T23:25:57","date_gmt":"2026-04-10T23:25:57","guid":{"rendered":"https:\/\/in.nau.edu\/human-research-protection-program\/?page_id=561"},"modified":"2026-04-14T23:37:24","modified_gmt":"2026-04-14T23:37:24","slug":"fda-regulated-research","status":"publish","type":"page","link":"https:\/\/in.nau.edu\/human-research-protection-program\/guidance\/fda-regulated-research\/","title":{"rendered":"FDA Regulated Research"},"content":{"rendered":"

FDA regulated research<\/strong><\/h1>\n

FDA regulated research refers to human subjects research that involves the use of medical devices,<\/strong> drugs, or biological <\/strong>products, that are regulated by the U.S. Food and Drug Administration (FDA). When a study involves a product that is intended to diagnose, cure, mitigate, treat, or prevent disease, or that affects the structure or function of the human body, FDA regulations may apply.<\/p>\n

Unlike human subjects research governed solely by the Common Rule (45 CFR 46), the FDA uses the term \u201cclinical investigation\u201d<\/strong> to describe research involving FDA\u2011regulated products. A clinical investigation is any experiment involving one or more human subjects and a test article<\/strong> (such as a drug or device) where the results are intended to be submitted to, or held for inspection by, the FDA.<\/p>\n

Studies that are FDA regulated must comply with both IRB requirements and applicable FDA regulations<\/strong>, including requirements related to informed consent, safety monitoring, and investigational product oversight.<\/p>\n

What is a medical device?<\/strong><\/h3>\n

Medical devices<\/strong><\/a><\/p>\n

A medical device is an instrument, apparatus, implement, machine, implant, or similar test article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of the body. Examples include Diagnostic, Investigational, In-Vitro, and Software as Medical Device. Medical devices do not achieve their primary intended purposes through chemical action or by being metabolized.<\/p>\n

Medical devices used in research are regulated by the FDA and are classified based on the level of risk they pose to participants.<\/p>\n

FDA device classifications<\/strong><\/a><\/p>\n

The FDA classifies medical devices into three categories: Class I, Class II, and Class III. The classification determines the level of regulatory oversight required.<\/p>\n

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Class I devices (low risk)<\/strong><\/h4>\n

Class I devices pose minimal potential risk to participants and are subject only to General Controls. These controls include requirements for registration, labeling, and good manufacturing practices.<\/p>\n

Examples may include:<\/p>\n