Source: https://www.law.cornell.edu/cfr/text/21/50.3
Timestamp: 2016-02-14 13:29:31
Document Index: 218591877

Matched Legal Cases: ['art 50', '§ 170', '§ 180', '§ 1010', '§ 1010', '§ 101', '§ 101', '§ 170', '§ 180', '§ 1010', '§ 1010', 'art 58']

21 CFR 50.3 - Definitions. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 50 › Subpart A › Section 50.3 21 CFR 50.3 - Definitions.
Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq. as amended (21 U.S.C. 321-392)).
Data and information about a substance submitted as part of the procedures for establishing that the substance is generally recognized as safe for use that results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in §§ 170.30 and 570.30.
Data and information about a food additive submitted as part of the procedures for food additives permitted to be used on an interim basis pending additional study, described in § 180.1.
Data and information about an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard, as described in § 1010.4.
Data and information about an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from a radiation safety performance standard, as described in § 1010.5.
Data and information submitted in a petition for a nutrient content claim, described in § 101.69 of this chapter, or for a health claim, described in § 101.70 of this chapter.
Assent means a child's affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Children means persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted.
Permission means the agreement of parent(s) or guardian to the participation of their child or ward in a clinical investigation.
(3) Data and information about a substance submitted as part of the procedures for establishing that the substance is generally recognized as safe for use that results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in §§ 170.30 and 570.30.
(4) Data and information about a food additive submitted as part of the procedures for food additives permitted to be used on an interim basis pending additional study, described in § 180.1.
(21) Data and information about an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard, as described in § 1010.4.
(22) Data and information about an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from a radiation safety performance standard, as described in § 1010.5.
Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug
Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug
Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug
Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.