Version
1.1
Date Updated
Wednesday, October 26, 2011
Descripton

DEFINITIONS


  1. CLINICAL INVESTIGATION: Any experiment in which a drug (or biologic or device)
    is administered or dispensed to, or used involving, one or more human subjects. In
    this context, experiment refers to any use of a drug except for the use of a marketed
    drug in the course of medical practice. (21 CFR 312.3(b))
  2. DRUG: A product that is intended for use in the diagnosis, cure, mitigation,
    treatment, or prevention of disease or intended to affect the structure or function of
    the body and achieves its intended effect through chemical action or metabolism
    within or on the body.
  3. FOOD AND DIETARY SUPPLEMENTS generally are not regulated as drugs.
    However, those that are intended or promoted to be used in the diagnosis, cure,
    mitigation, treatment or prevention of disease are considered drugs.
  4. BIOLOGIC: A biological or related product derived from living sources (e.g., humans,
    animals, microorganisms) and regulated by the FDA, including blood, vaccines,
    allergenics, tissues and cellular and gene therapies. Studies of unlicensed biologics
    are generally regulated according to the IND regulations. FDA regulations related to
    the general use and licensing of biologics are found in 21 CFR 600 and 601.
  5. INVESTIGATIONAL NEW DRUG APPLICATION (IND): An IND exempts an
    investigational new drug from pre-marketing approval requirements that would
    otherwise by applicable and allows the drug to be lawfully shipped for the purpose of
    conducting clinical investigations of that drug (21 CFR 312.1(a)).
  6. INVESTIGATIONAL NEW DRUG refers to an unapproved drug or biologic (or
    approved drug or biologic for an unapproved indication) used in an FDA-regulated
    clinical investigation. The term also includes biological products used in vitro for
    diagnostic purposes. Clinical investigations that involve FDA regulated drugs are
    subject to the requirements of 21 CFR 312.
  7. DEVICE is an instrument, apparatus, machine or similar article that is used for
    the diagnosis, mitigation, cure, prevention or treatment of disease and does not work
    through chemical action or metabolism within the body.
  8. INVESTIGATIONAL DEVICE EXEMPTION APPLICATION (IDE): An IDE
    exempts an unapproved or uncleared device (or an approved or cleared device for
    an unapproved or uncleared indication) in a research study involving humans (i.e.,
    an IDE is an investigational exemption) from certain statutes and regulations. With
    this exemption, the unapproved or uncleared device can be shipped and used in
    human research.
  9. INVESTIGATIONAL DEVICE: Medical device that is the subject of a clinical study
    designed to evaluate the effectiveness or safety of the device, or a clinical evaluation
    of certain modifications or new intended uses of a legally marketed device. Clinical
    investigations that involve FDA regulated devices are subject to the requirements of
    21 CFR 812.
  10. PREMARKET APPROVAL (PMA) APPLICATION: A PMA is the most stringent type
    of marketing application for medical devices, FDA approves a PMA based on
    presence of sufficient valid scientific evidence and reasonable assurance that the
    device is safe and effective for its intended use. Once approved, it can be marketed
    and sold within its approved labeling.
  11. PREMARKET NOTIFICATION (510(K)): A 510(k) application is submitted to FDA
    before a manufacturer plan to market a device. If the FDA agrees that the new
    device is substantially equivalent to a legally marketed device for which a PMA is not
    required, the manufacturer may market it immediately. FDA does not require clinical
    data for most 510(k)s. However, if clinical data are necessary to demonstrate
    equivalence, the clinical study must comply with IDE, IRB and human subject
    protection regulations.
  12. SIGNIFICANT RISK DEVICE: Significant risk device (SR) is an investigational
    device that: (1) is intended as an implant and presents a potential for serious risk to
    the health, safety, or welfare of a subject; (2) is for use in supporting or sustaining
    human life and represents a potential for serious risk to the health, safety, or welfare
    of a subject; (3) is for a use of substantial importance in diagnosing, curing,
    mitigating, or treating disease or otherwise preventing impairment of human health
    and presents a potential for serious risk to the health, safety, or welfare of a subject;
    or (4) otherwise presents a potential for serious risk to a subject. The SR
    determination encompasses the proposed use and not the device alone (e.g., need
    for additional procedures, such as surgical implantation, as part of the study should
    be included in risk assessment.
  13. NONSIGNIFICANT RISK DEVICE: A device not meeting the definition of SR
    device. Please see examples of significant and nonsignificant risk devices.