Regulatory Pathways for Medical Innovation

When researchers and clinicians bring new medical advancements to light, they must navigate distinct regulatory pathways established by the U.S. Food and Drug Administration (FDA). These frameworks ensure that unapproved drugs and medical devices can be safely evaluated in clinical trials or distributed to patients with rare conditions under strict oversight. Depending on whether the innovation is a pharmaceutical, a standard medical device, or a specialized tool for rare diseases, it falls into one of three critical FDA categories: IND, IDE or HUD.

FDA regulatory pathways for clinical research and specialized patient care

  • Investigational New Drug
    6/16/26
    An Investigational New Drug (IND) is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy.
  • Investigational Device Exemption
    6/16/26
    An Investigational Device Exemption (IDE) allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).
  • Humanitarian Use Device
    6/16/26
    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 or is manifested in fewer than 4,000 individuals in the United States per year.