§1169.3. Definitions
As used in this Subpart, the following terms have the meaning ascribed to them in
this Section:
(1)"Eligible patient" means a person to whom all of the following criteria apply:
(a)Has a terminal illness.
(b)As determined by the person's physician, has no comparable or satisfactory
treatment options that are approved by the United States Food and Drug Administration and
available to diagnose, monitor, or treat the person's disease or condition, and the probable
risk to the person from the investigational drug, biological product, or device is not greater
than the probable risk from the person's disease or condition.
(c)Has received a prescription or recommendation from his physician for an
investigational drug, biological product, or device.
Free access — add to your briefcase to read the full text and ask questions with AI
§1169.3. Definitions
As used in this Subpart, the following terms have the meaning ascribed to them in
this Section:
(1) "Eligible patient" means a person to whom all of the following criteria apply:
(a) Has a terminal illness.
(b) As determined by the person's physician, has no comparable or satisfactory
treatment options that are approved by the United States Food and Drug Administration and
available to diagnose, monitor, or treat the person's disease or condition, and the probable
risk to the person from the investigational drug, biological product, or device is not greater
than the probable risk from the person's disease or condition.
(c) Has received a prescription or recommendation from his physician for an
investigational drug, biological product, or device.
(d)(i) Has given his consent in writing for the use of the investigational drug,
biological product, or device; or, if he is a minor or lacks the mental capacity to provide
consent, a parent or legal guardian has given consent in writing on his behalf.
(ii) A person who can understand and comprehend spoken English but is physically
unable to talk or write may be deemed as meeting the criteria of this Subparagraph if he is
competent and able to indicate consent by other means.
(e) Has documentation from his physician indicating that he has met the
requirements provided in this Subpart.
(2)(a) "Investigational drug, biological product, or device" means a drug, biological
product, or device that has successfully completed phase one of a United States Food and
Drug Administration approved clinical trial, but has not been approved for general use by the
United States Food and Drug Administration and remains under investigation in a clinical
trial.
(b) Notwithstanding Subparagraph (a) of this Paragraph, for purposes of this Subpart,
"investigational drug, biological product, or device" shall include any device possessing the
following characteristics regardless of whether it has successfully completed phase one of
a United States Food and Drug Administration approved clinical trial:
(i)(aa) If of a robotic nature, the device is designed such that any failure in a
multitude of continuous tests of its internal subsystems should cause motion to stop,
consistent with the Guidelines For Robotics Safety from the Occupational Safety and Health
Administration of the United States Department of Labor (Directive Number STD
01-12-002).
(bb) For purposes of this Item, "robotic nature" shall mean capable of independent
motion or moving the user.
(ii) The device has all of the following features for intentional control:
(aa) The motion of the device responds to specific controls from the user.
(bb) The device has no machine state in which motion continues without a specific
command from the user.
(iii) The device has an emergency stop button which allows an assistant to force the
motion of the device to stop.
(3) "Terminal illness" means a disease that, without life-sustaining procedures, will
result in death in the near future or a state of permanent unconsciousness from which
recovery is unlikely. This diagnosis shall be confirmed by a second independent evaluation
by a board-certified physician in an appropriate speciality.