Applicant

For device submissions the applicant is usually the manufacturer. The applicant carries the responsibilities attached to the submission, including financial disclosure for clinical investigators under 21 CFR 54.

Applicant means the party who submits a marketing application to FDA for approval of a drug, device, or biologic product. The applicant is responsible for submitting the appropriate certification and disclosure statements required in this part.

21 CFR, 54.2

Applicant means any person who submits or plans to submit an application to the Food and Drug Administration for premarket review. For purposes of this section, the terms “sponsor” and “applicant” have the same meaning. (d) Biological product has the meaning given the term in section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)).

21 CFR, 3.2

21 CFR 3.2 covers anyone who submits or plans to submit an application for premarket review and treats applicant and sponsor as the same. 21 CFR 54.2 refers to the party that submits a marketing application and makes it responsible for the investigators' financial certification and disclosure statements.