Essure Discontinuation Doesn’t Mean the End to FDA Scrutiny
Bayer has already decided to stop selling the controversial birth control device, but FDA says it will continue to monitor the long-term safety of Essure.
Is Progress on MDR and IVDR Happening Fast Enough?
One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), industry experts continue to express concern that more progress is needed to help companies prepare for the new regulations within the limited transition period.
8 Things You Should Know about the EU MDRs
Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared?
6 Questions to Ask Yourself about ISO 11607 Compliance
These FDA-consensus standards guide packaging design and validation—how compliant are you, and how ready are you for the upcoming revision?
FDA Medical Device Safety Action Plan: Good or Bad for Medtech?
FDA’s five-pronged Medical Devices Safety Action Plan, revealed in April, has triggered concern by AdvaMed, Johnson & Johnson, and physician specialty groups.
Should Medical Devices Come with Expiration Dates?
Implantable medical devices containing highly sophisticated electronics are lasting longer than before, raising the bar for safety and liability.
