---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-013836"
form_type: "8-K"
ticker: "INBS"
cik: "0001725430"
company_name: "INTELLIGENT BIO SOLUTIONS INC."
filed_at: "2025-09-17T23:59:59+00:00"
generated_at: "2026-05-17T06:22:42.210929+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Intelligent Bio Solutions must resubmit FDA 510(k) for drug screening system after new info request

## Summary
- FDA requested new additional information in a letter dated September 12, 2025, requiring a new 510(k) resubmission.
- Company previously responded to a February 2025 AI request covering over 70 items and submitted additional data in August 2025.
- First-of-its-kind sweat-based device; FDA feedback described as not uncommon for breakthrough technologies.
- Company expects an investor update within ten days outlining a revised timeline for FDA clearance.
- International commercial activities continue to grow outside the U.S. while pursuing clearance.

## SEC filing metadata
- accession: 0001493152-25-013836
- form_type: 8-K
- ticker: INBS
- cik: 0001725430
- company_name: INTELLIGENT BIO SOLUTIONS INC.
- filed_at: 2025-09-17T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1725430/000149315225013836/0001493152-25-013836-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1725430/000149315225013836/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-013836
- JSON: https://secwatch.observer/filing/0001493152-25-013836.json
- Plain text: https://secwatch.observer/filing/0001493152-25-013836.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.