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D.C. Municipal Regulations (Last Updated: September 13, 2017) |
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Title 22. HEALTH |
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SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
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Chapter 22-B109. INVESTIGATIONAL DEVICE EXEMPTIONS |
Section 22-B10999. DEFINITIONS
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10999.1 As used in this chapter, the following terms shall have the meanings ascribed:
Act –the Federal Food, Drug, and Cosmetic Act. approved June 25, 1938, 21 U.S.C. § 301, et seq.
Custom device - a device that:
(a)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;
(b)Is not generally available to, or generally used by, other physicians or dentists;
(c)Is not generally available in finished form for purchase or for dispensing upon prescription;
(d)Is not offered for commercial distribution through labeling or advertising; and
(e)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.
Department – District of Columbia Department of Health.
DOH – District of Columbia Department of Health.
Implant – 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 thirty (30) days or more. The Department may, in order to protect public health, determine that devices placed in subjects for shorter periods are also “implants” for purposes of this part.
Institution – 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 21 U.S.C. § 360j(g).
Institutional review board (IRB) – 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 21 C.F.R., part 56. The term has the same meaning as “institutional review committee” in 21 U.S.C. § 360j(g).
Investigational device – a device, including a transitional device, that is the object of an investigation.
Investigation – a clinical investigation or research involving one (1) or more subjects to determine the safety or effectiveness of a device.
Investigator – an individual who actually conducts a clinical investigation (for example, 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.
Monitor (n) – 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 (v) – to oversee an investigation.
Noninvasive – when applied to a diagnostic device or procedure, means one that does not by design or intention:
(a)Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or
(b)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 non-investigational purposes is also considered noninvasive.
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.
Significant risk device – an investigational device that:
(a)Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
(b)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;
(c)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
(d)Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
Sponsor – 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 (1) 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.
Sponsor-investigator – 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 section include those of an investigator and those of a sponsor.
Subject – 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.
Termination – a discontinuance, by sponsor or by withdrawal of IRB or the Department approval, of an investigation before completion.
Transitional device – a device subject to 21 U.S.C. § 360(j)(l), that is, a device that the Department considered to be a new drug or an antibiotic drug before May 28, 1976.
Unanticipated adverse device effect – 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.