clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;
clinical investigation means the investigation to be conducted at the Investigation Site in accordance with the Clinical Investigation Plan numbered […insert identification number…].
clinical investigation means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness;
More Definitions of clinical investigation
clinical investigation means any experiment that involves a test article and one or more human participants and that is one of the following: [21 CFR 50.3(c) and 21 CFR 56.102(c)]
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 sub- ject to requirements for prior submis- sion to the Food and Drug Administra- tion under these sections of the act, but the results of which are intended to be submitted later to, or held for in- spection by, the Food and Drug Admin- istration 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.
clinical investigation means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i), 507(d), or 520(g) of the act, or need not meet the 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 later submitted 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 must meet the provisions of Part 58, regarding nonclinical laboratory studies. The terms "research," "clinical research," "clinical study," "study," and "clinical investigation" are deemed to be synonymous for purposes of this part.
clinical investigation means any designed and planned systematic study undertaken on human subjects to verify the safety or performance of a specific medical device;
clinical investigation means any experiment involv-
clinical investigation means a systematic investigation of a medical device – with the exception of in vitro diagnostic devices – in a trial subject, which is carried out with the aim
clinical investigation means any experiment that involves a test article and one or more human subjects, and that either must meet the require- ments for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior sub- mission to the Food and Drug Adminis- tration under these sections of the act, but the results of which are intended to be later submitted to, or held for in- spection by, the Food and Drug Admin- istration as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58, re- garding nonclinical laboratory studies.