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Form Approved: OMB No. 09100396 Expiration Date: March 31, 2019DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug AdministrationDISCLOSURE: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORS.
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Applicable FAQ
Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: “no clinical studies were performed to test this device.”
applicants may submit a single FORM FDA 3455, with attachments clearly identifying all clinical investigators with information to disclose and, for each investigator, identifying the study, the specific details of their financial interests and arrangements and the steps taken to minimize the potential for bias.
Form FDA 3454. Certification: Financial Interests and Arrangements of Clinical Investigators. Form FDA 3455. Disclosure: Financial Interests and Arrangements of Clinical Investigators. MedWatch Forms: FDA Medical Product Reporting Program.
§ 54.4 Certification and disclosure requirements. The applicant is required to submit for each clinical investigator who participates in a covered study, either a certification that none of the financial arrangements described in § 54.2 exist, or disclose the nature of those arrangements to the agency.
Complete form 3454 if none of the investigators have any FDA required disclosures. Complete form 3455 if any clinical investigator has a financial disclosure that is significant.
Gov Related content
Financial Disclosure by Clinical Investigators
Feb 8, 2013 — applicants may submit a single FORM FDA 3455, with attachments clearly...
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