[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.3]

[Page 99-101]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 812.3  Definitions.

    (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 
201-901, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)).
    (b) Custom device means a device that:
    (1) Necessarily deviates from devices generally available or from an 
applicable performance standard or premarket approval requirement in 
order to comply with the order of an individual physician or dentist;
    (2) Is not generally available to, or generally used by, other 
physicians or dentists;
    (3) Is not generally available in finished form for purchase or for 
dispensing upon prescription;
    (4) Is not offered for commercial distribution through labeling or 
advertising; and
    (5) Is intended for use by an individual patient named in the order 
of a physician or dentist, and is to be made in a specific form for that 
patient, or is intended to meet the special needs of the physician or 
dentist in the course of professional practice.
    (c) FDA means the Food and Drug Administration.
    (d) Implant means a device that is placed into a surgically or 
naturally formed cavity of the human body if it

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is intended to remain there for a period of 30 days or more. FDA may, in 
order to protect public health, determine that devices placed in 
subjects for shorter periods are also ``implants'' for purposes of this 
part.
    (e) Institution means a person, other than an individual, who 
engages in the conduct of research on subjects or in the delivery of 
medical services to individuals as a primary activity or as an adjunct 
to providing residential or custodial care to humans. The term includes, 
for example, a hospital, retirement home, confinement facility, academic 
establishment, and device manufacturer. The term has the same meaning as 
``facility'' in section 520(g) of the act.
    (f) Institutional review board (IRB) means any board, committee, or 
other group formally designated by an institution to review biomedical 
research involving subjects and established, operated, and functioning 
in conformance with part 56. The term has the same meaning as 
``institutional review committee'' in section 520(g) of the act.
    (g) Investigational device means a device, including a transitional 
device, that is the object of an investigation.
    (h) Investigation means a clinical investigation or research 
involving one or more subjects to determine the safety or effectiveness 
of a device.
    (i) Investigator means an individual who actually conducts a 
clinical investigation, i.e., under whose immediate direction the test 
article is administered or dispensed to, or used involving, a subject, 
or, in the event of an investigation conducted by a team of individuals, 
is the responsible leader of that team.
    (j) Monitor, when used as a noun, means an individual designated by 
a sponsor or contract research organization to oversee the progress of 
an investigation. The monitor may be an employee of a sponsor or a 
consultant to the sponsor, or an employee of or consultant to a contract 
research organization. Monitor, when used as a verb, means to oversee an 
investigation.
    (k) Noninvasive, when applied to a diagnostic device or procedure, 
means one that does not by design or intention: (1) Penetrate or pierce 
the skin or mucous membranes of the body, the ocular cavity, or the 
urethra, or (2) enter the ear beyond the external auditory canal, the 
nose beyond the nares, the mouth beyond the pharynx, the anal canal 
beyond the rectum, or the vagina beyond the cervical os. For purposes of 
this part, blood sampling that involves simple venipuncture is 
considered noninvasive, and the use of surplus samples of body fluids or 
tissues that are left over from samples taken for noninvestigational 
purposes is also considered noninvasive.
    (l) Person includes any individual, partnership, corporation, 
association, scientific or academic establishment, Government agency or 
organizational unit of a Government agency, and any other legal entity.
    (m) Significant risk device means 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 purported or represented to be for a use in supporting or 
sustaining human life and presents 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 the health, 
safety, or welfare of a subject.
    (n) Sponsor means a person who initiates, but who does not actually 
conduct, the investigation, that is, the investigational device is 
administered, dispensed, or used under the immediate direction of 
another individual. A person other than an individual that uses one or 
more of its own employees to conduct an investigation that it has 
initiated is a sponsor, not a sponsor-investigator, and the employees 
are investigators.
    (o) Sponsor-investigator means an individual who both initiates and 
actually conducts, alone or with others, an investigation, that is, 
under whose immediate direction the investigational device is 
administered, dispensed, or used. The term does not include any person 
other than an individual. The

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obligations of a sponsor-investigator under this part include those of 
an investigator and those of a sponsor.
    (p) Subject means a human who participates in an investigation, 
either as an individual on whom or on whose specimen an investigational 
device is used or as a control. A subject may be in normal health or may 
have a medical condition or disease.
    (q) Termination means a discontinuance, by sponsor or by withdrawal 
of IRB or FDA approval, of an investigation before completion.
    (r) Transitional device means a device subject to section 520(l) of 
the act, that is, a device that FDA considered to be a new drug or an 
antibiotic drug before May 28, 1976.
    (s) Unanticipated adverse device effect means any serious adverse 
effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or 
welfare of subjects.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 48 
FR 15622, Apr. 12, 1983]