Before tackling 2024, a quick overview of the articles from the last half of 2023 written for the DM Experts flash.
TGA : Update of guidelines on clinical evidence
FDA : eStar Platform Update for PMA Submission Pilot Project
Lots of movement on the US market side with new developments and updates brought by the FDA. A rich news story, in line with the skills of our team concerning obtaining marketing authorizations for medical devices on American territory (510(k), PMA, DeNovo, etc.).
If you are concerned by one of these subjects and you need more information, do not hesitate to let us know your request.