Background and COntext

The FDA's Small Business Determination (SBD) program allows eligible businesses to qualify for reduced user fees before submitting a regulatory application. The original digital experience (SBD V1) required users to download, fill out, and upload PDFs containing business information, which is a process prone to errors, omissions, and inconsistencies. As part of the FDA's broader Digital Transformation (DT) program, SBD was selected for improvement. I took on the UX lead role as SBD V1 was being implemented and V2 planning began. My focus was to evolve the experience from a static upload form to a more dynamic, guided web form aligned with enterprise standards and internal FDA review processes.

Problem Space

SBD V1 had several key challenges:

  • Limited validations, allowing for incomplete or inaccurate submissions.
  • A heavy reliance on PDF uploads for critical data
  • No visibility into what happens after the user clicks "submit"
  • UI inconsistencies that made the experience difficult to follow

This raised broader questions: How is this data used internally? How does it reach reviewers? And how can we improve both the applicant's and the agency's experience?

My role

I led UX efforts for SBD V2, working across discovery, audit, design, and Agile implementation. I collaborated with product owners, developers, and policy stakeholders to:

  • Audit the current UI and identify inconsistencies
  • Design key improvements to the webform
  • Define validation logic and dynamic behaviors
  • Explore how submitted data is handled internally

Key Contributions

UI Audit & Standards Alignment

I began by auditing the SBD V1 UI, identifying inconsistencies in buttons, spacing, layout, and form behavior. Many of these patterns diverged from FDA's enterprise design standards (Constellation/Cosmos React). I developed recommendations to bring the experience into alignment, ensuring visual consistency, clarity, and predictable interactions.

Digital Information Entry

One of the most impactful changes I led was replacing the need for users to upload a separate PDF containing business information. In SBD V2, applicants could now enter that information directly into the web form. This not only reduced friction for users but significantly improved the quality and structure of submitted data.

Validation at Every Step

I worked closely with developers to introduce real-time validations at each step of the form. This ensured that incomplete or incorrectly formatted information could be flagged and corrected before submission—saving both the user and internal FDA teams time and effort.

Investigating the Post-Submission Experience

While designing improvements for the applicant experience, I began asking: "What happens after the user clicks submit?" This led me to investigate the FDA's internal Document Control Center (DCC) process. I discovered that all submissions pass through the DCC for validation, transcription, and formatting before they are reviewed.

Expanding the Lens: Mapping the DCC Process

To better understand how submission design impacts internal processing, I mapped the end-to-end DCC workflow, including:

  • Submission intake (paper or electronic)
  • System assignment (e.g., Century)
  • Verification and transcription (manual entry or loader tool)
  • Quality checks and finalization for reviewer readiness

This journey map helped identify key friction points and manual steps that could be improved if upstream submission forms (like SBD) were designed with those needs in mind.

Insights from DCC Journey Mapping

  • Manual Transcription Bottlenecks: Many submissions required rekeying of information into internal systems, which delayed processing.
  • File Format Issues: Format mismatches or incorrect uploads from industry users resulted in back-and-forth corrections.
  • Lack of Feedback Loops: Submitters were unaware of issues until long after submission, increasing frustration and support needs.
  • Missed Opportunities for Automation: With better structured data (like from SBD V2), auto-ingest into transcription tools could reduce workload and errors.
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Cross Team Facilitation & Impact

I facilitated cross-functional discussions between the SBD, DCC team and internal tools team ( CTS & CEntry). These conversations suirfaced the opportunity for auto -ingestion ( automatically transferring structered data from webform into internal trasncription tools.

By advocating for this connection between frontend experience and backend review wqorkflows, I helped shift the conversation from form usability to submisison lifecycle efficiency.