0338 21cfr601 33 2007

§ 601.30

21 CFR Ch. I (4–1–05 Edition)

the CBER list from the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration (see
mailing addresses in § 600.2 of this chapter).

carrier or ligand component of the diagnostic radiopharmaceutical); and
(c) The estimated absorbed radiation
dose of the diagnostic radiopharmaceutical.

[65 FR 56480, Sept. 19, 2000, as amended at 70
FR 14984, Mar. 24, 2005]

(a) For diagnostic radiopharmaceuticals, the categories of proposed
indications for use include, but are not
limited to, the following:
(1) Structure delineation;
(2) Functional, physiological, or biochemical assessment;
(3) Disease or pathology detection or
assessment; and
(4) Diagnostic or therapeutic patient
management.
(b) Where a diagnostic radiopharmaceutical is not intended to provide disease-specific information, the proposed
indications for use may refer to a biochemical, physiological, anatomical, or
pathological process or to more than
one disease or condition.

§ 601.33

Subpart D—Diagnostic
Radiopharmaceuticals
SOURCE: 64 FR 26668, May 17, 1999, unless
otherwise noted.

§ 601.30

Scope.

This subpart applies to radiopharmaceuticals intended for in vivo administration for diagnostic and monitoring
use. It does not apply to radiopharmaceuticals intended for therapeutic purposes. In situations where a particular
radiopharmaceutical is proposed for
both diagnostic and therapeutic uses,
the radiopharmaceutical must be evaluated taking into account each intended use.
§ 601.31

§ 601.34

Evaluation of effectiveness.

(a) The effectiveness of a diagnostic
radiopharmaceutical is assessed by
evaluating its ability to provide useful
clinical information related to its proposed indications for use. The method
of this evaluation varies depending
upon the proposed indication(s) and
may use one or more of the following
criteria:
(1) The claim of structure delineation
is established by demonstrating in a
defined clinical setting the ability to
locate anatomical structures and to
characterize their anatomy.
(2) The claim of functional, physiological, or biochemical assessment is
established by demonstrating in a defined clinical setting reliable measurement of function(s) or physiological,
biochemical, or molecular process(es).
(3) The claim of disease or pathology
detection or assessment is established
by demonstrating in a defined clinical
setting that the diagnostic radiopharmaceutical has sufficient accuracy
in identifying or characterizing the disease or pathology.
(4) The claim of diagnostic or therapeutic patient management is established by demonstrating in a defined
clinical setting that the test is useful

Definition.

For purposes of this part, diagnostic
radiopharmaceutical means:
(a) An article that is intended for use
in the diagnosis or monitoring of a disease or a manifestation of a disease in
humans and that exhibits spontaneous
disintegration of unstable nuclei with
the emission of nuclear particles or
photons; or
(b) Any nonradioactive reagent kit or
nuclide generator that is intended to
be used in the preparation of such article as defined in paragraph (a) of this
section.
§ 601.32 General factors relevant
safety and effectiveness.

Indications.

to

FDA’s determination of the safety
and effectiveness of a diagnostic radiopharmaceutical includes consideration
of the following:
(a) The proposed use of the diagnostic
radiopharmaceutical in the practice of
medicine;
(b) The pharmacological and toxicological activity of the diagnostic
radiopharmaceutical (including any

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