Intelligent Bio Solutions Inc. (Nasdaq: INBS) provided an update on its FDA 510(k) clearance process for the Intelligent Fingerprinting Drug Screening System.
The FDA issued an Additional Information request in February 2025 with over 70 items to address, requiring INBS to provide extensive supporting information for the first-of-its-kind device.
The Company is in consultation with specialized FDA consultants and aims to resubmit a new 510(k) notification to satisfy the FDA's requirements.
FDA 510(k) Clearance Process Update
INBS responded to the FDA's Additional Information request with specialized support, preparing to resubmit the 510(k) notification.
Technological Validation
The FDA's feedback validates the need for comprehensive information to support the innovative nature of the Intelligent Fingerprinting Drug Screening System.
Commercial Progress and Global Expansion
While pursuing FDA clearance, INBS continues to expand internationally and enhance commercial activities across various sectors outside the U.S.
- The FDA's request for additional information and the need for a new 510(k) notification indicate the regulatory challenges faced by INBS.
- INBS remains optimistic about the capabilities of its technology and is committed to meeting the FDA's requirements to bring the Intelligent Fingerprinting Drug Screening System to the U.S. market.
Intelligent Bio Solutions Inc. is actively responding to the FDA's feedback to progress its FDA 510(k) clearance process for the Intelligent Fingerprinting Drug Screening System. The Company's commitment to meeting regulatory demands aligns with its vision to revolutionize non-invasive testing solutions.