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What is the difference between Form FDA 3601, 3514, 3881, and 3454?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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