Intelligent Bio Solutions Receives FDA Feedback, Preparing To Resubmit 510(k) For Intelligent Fingerprinting Drug Screening System

Intelligent Bio Solutions Inc. (NASDAQ:INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today provided an update on its FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System.

In December 2024, INBS submitted its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent Fingerprinting Drug Screening System. As expected, the FDA reviewed and responded with questions by issuing an Additional Information (AI) request in February 2025. This AI request consisted of over 70 items to be addressed by the Company. With the support of specialized FDA consultants and expert third-party partners, INBS responded to the FDA's questions and submitted additional information in August 2025.   

The FDA appeared to be satisfied with the majority of responses to the items and has responded with a request for new additional information that requires the Company to resubmit a new 510(k) notification. As a first-of-its-kind device with no comparable cleared or approved sweat-based product currently on the market, the Company's Intelligent Fingerprinting Drug Screening System requires extensive supporting information to validate its performance. The practical feedback received from the FDA is not uncommon for breakthrough technologies.

INBS is in the process of evaluating the FDA's questions and is currently in consultation with its specialized FDA consultants. The Company expects to have an investor update in the next ten days outlining an updated timeline for FDA clearance.