[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR812.3]



[Page 100-101]

 

                        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 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



[[Page 101]]



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 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]