Innovative Health Solutions asks FDA to require pre-clinical and clinical trials for any proposed devices demonstrating substantial equivalence to its...
FDA announces the availability of four International Council on Harmonization drug guidances.
FDA clears a Lensar 510(k) for the Lensar Laser System with Streamline IV, that expands the platforms capabilities to include the creation of the corn...
Federal Register notice: FDA seeks comments on an information collection extension for Petition To Request an Exemption From 100% Identity Testing of ...
FDA allows the de novo marketing of called IDx LLC.s IDx-DR, a software program that uses an artificial intelligence algorithm to analyze images of th...
FDA clears a Johnson & Johnson Vision Care 510(k) for the first contact lens to incorporate an additive that automatically darkens the lens when expos...
Federal Register notice: FDA submits for OMB approval an information collection extension for Class 2 Special Controls Guidance Document: Labeling for...
FDA denies an Insys Therapeutics petition asking for restrictions on ANDAs for a generic form of its Syndros.