About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

Form FDA 3601, or the Medical Device User Fee Cover Sheet, is used to indicate the type of exception that applies in the case of 510(k) submissions. It is:

  • intended solely for pediatric use, or
  • submitted by a state or Federal government entity.

Form FDA 3514, or the CDRH Premarket Review Submission Cover Sheet, is a voluntary form used to help provide basic administrative info for all types of premarket notification submissions.

Form FDA 3881, or the Indications for Use Statement, should have the same information as the indications for use listed throughout the rest of the 510(k), including device labeling. It should identify whether the device is for prescription and/or over-the-counter use.

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.”

  • Financial Certification: for if the clinical investigators were not paid enough money that it might impact results
  • Disclosure Statement: for if the clinical investigators were paid and how bias was mitigated

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