---
AI Summary: "\\- Resolved FDA hold letter for an AI/ML enabled software as a medical\
  \ device.  \n- Secured FDA clearance without repeating clinical study.  \n- Streamlined\
  \ communication and identified unnecessary software requirements to minimize additional\
  \ validation work."
Anonymous: false
Assignee:
- Yujan Shrestha
Last Edited Time: '2026-01-25T23:20:00+00:00'
client_logo:
- 18abd5b7-a754-8055-be57-d8d7fdba3717
client_name: SimBioSys
date: '2024-02-09'
featured: true
medical_panel: Radiology
name: We resolved a hold letter that threatened a clinical study redo and got it 510(k)
  cleared on Christmas Day.
services:
- 0e5a8b75-a1ca-404b-843a-a7b5943fe868
summary: Resolved FDA hold letter that would have required repeating the entire clinical
  study. Cleared shortly after.
tags:
- AI/ML
testimonials:
- cd65edac-fca0-4101-9c16-ad50739ab37a
---

- 
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## The Problem

The client had submitted a 510k for an AI/ML enabled software as a medical device. The FDA issued an additional information (AI) letter with a lot of tough questions surrounding the clinical performance study. The client was looking for a regulatory strategist to help them address FDA\'s concerns with the least amount of effort and shortest time possible.

## The Outcome

The client secured FDA clearance soon after several rounds of correspondences with the FDA, all under our guidance. Even the client was pleasantly surprised by the clearance.

## The Solution

We began by reviewing all correspondences with the FDA, including the original submission, the FDA hold letter and the client\'s preliminary responses. We identified several software requirements that were extra risk control measures that were going above and beyond what is needed for the regulations. We successfully resolved FDA's concerns and thereby sidestepped a lot of unnecessary verification and validation work. One finding in particular, would have caused the client to repeat their entire clinical performance study but we were able to find a pathway forward that did not require any additional work. The client recently received an FDA clearance letter, even when the client\'s team did not expect to receive.