A look back at the articles written for DM Experts Flash

Before tackling 2024, a quick overview of the articles from the last half of 2023 written for the DM Experts flash.

Articles written for flash 114 (August 2023)

FDA : Medical Device Material Safety Summary
Survey of companies on their state of preparedness for EUDAMED
Team NB : Transfer Agreement for Monitoring Activities for Legacy Devices

Articles written for flash 115 (September 2023)

FDA : Draft Guidance Document on Use of Clinical Data for 510(k) Submissions
FDA : Draft Guidance Document on Specific Expectations for 510(k) Submissions of Implantable Devices
FDA : Draft Guidance Document on Predicate Selection for 510(k) Submissions

Articles written for flash 116 (October 2023)

FDA : Update of the MDSAP guide on the QMS manual
FDA : Update of the guide for testing and labeling of medical devices in magnetic resonance environments
FDA : Guidance on Testing and Labeling of MDs for Safety in the Magnetic Resonance (MR) Environment

Articles written for flash 117 (November 2023)

EUDAMED : Update of guides concerning the IUD
Extension of the authorisation to use DEHP in medical devices in Europe

Articles written for flash 118 (December 2023)

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.