Financial Certification or Disclosure Statement is one of the sections of FDA 510k submission that mentions a single statement like “This section is not applicable as no clinical studies were performed to test this device” if no clinical evaluation studies are performed. If performed clinical studies on the device the FDA has provided the two forms for use.
The forms are:
- Form FDA 3454 – Certification: Financial interests and arrangements of clinical investigators.
- Form FDA 3455 – Disclosure: Financial interests and arrangements of clinical investigators.
- The Financial Certification is required if applicant did not pay the clinical investigators. It means payment done only for the costs of the study, there is no integrity or payment of any other kind (such as a grant) given to the clinical investigators.
- The Disclosure Statement is used if applicant paid the clinical investigators. Part of that form includes submitting the details of how applicant mitigated any bias.
- The manufacturer should comply with the 21 CFR 54 Financial Certification or Disclosure Statement requirements for 510(k) submission.
