How Early FDA Engagement Can Accelerate Medical Device Approval & Reduce Market Delays

By interacting with FDA as early as medical device conception, and taking advantage of one or more FDA programs, manufacturers can shorten their time to market and significantly reduce expenditures.

From the Editor – FDA’s Final Rule on LDTs Raises Concerns for Personalized Medicine

Arecent report from data and analytics firm GlobalData finds that FDA’s final rule on laboratory developed tests’ (LDT) hampers innovation and puts the future of these devices in limbo. With the FDA’s final rule on LDTs on the horizon, clinical laboratories, manufacturers, and patients have raised concerns about its potential impact on the U.S.

What the EU Parliament’s Resolution Means for MDR and IVDR

The resolution represents a non-binding legal intention to consider further changes.

Staying on the compliant side of change control regulations

Medical device change control regulations have a lot of boxes to check.

New FDA Regulations for Laboratory Developed Tests (LDTs): What it Means to Laboratories

As IUD demand surges, CooperSurgical designs new Paragard placement system

5 tips for meeting new device packaging regulations before it’s too late

Noncompliance with European packaging waste directives mean fines or worse for device makers, so take this expert advice on designing for recyclability with innovative materials, testing and more.

Risk Management in Medical Devices: Harmonizing ISO 14971-2019 & FDA QMSR

nsuring the safety and efficacy of medical devices/IVDs is paramount in the healthcare industry. This critical objective is achieved through comprehensive risk management practices, and two key frameworks play a crucial role: ISO 14971:2019 and the FDA Quality Management System Regulation (QMSR). This essay explores their individual contributions and how they work synergistically to enhance medical device safety.

Transitioning EU Clinical Trials: Key Steps for Compliance by 2025

To streamline processes, enhance transparency, and improve the overall efficiency of conducting clinical trials in the EU/EEA, the 3-year transition period from the CTD to the CTR requirements was established. With the end of the transition period approaching, all ongoing clinical trials that were approved under the CTD will have to be fully be transitioned to comply with the CTR. Failure to comply by 2025 will bring serious consequences.

2024 Medtech FDA Approval Volume Trends Down