Nasdaq

Intelligent Bio Solutions Inc. Submits FDA 510(k) Application for Intelligent Fingerprinting Drug Screening System

Intelligent Bio Solutions Inc. (INBS) has submitted a 510(k) premarket notification to the FDA for its Intelligent Fingerprinting Drug Screening System, a rapid and non-invasive drug testing method ...
Nasdaq

Spectral AI Submits De Novo 510k Application to FDA for DeepView® System Designed for Burn Care Diagnostics

Spectral AI submitted a De Novo 510k application for its DeepView System to the FDA, aimed at enhancing burn care. Spectral AI has announced the submission of its De Novo 510k marketing clearance ...
RAPS

FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) ...
RAPS

New guidances outline eSTAR submission requirements for de novo and 510(k) device applications

The US Food and Drug Administration is one step closer to requiring electronic submission of all premarket applications for both 510(k) and de novo medical devices, according to two newly released ...
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

The US Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), regulates medical devices and radiation-emitting products. 1 The 510(k) clearance process, ...