Across medical device and IVD inspections, U.S. Food and Drug Administration (FDA) continues to issue Form 483 observations and Warning Letters tied to risk management failures. These findings are not about missing templates, they reflect [...]

In a move aimed at strengthening patient safety and enhancing transparency, the FDA’s Center for Devices and Radiological Health (CDRH) has announced a new communications pilot program that seeks to reduce the time between the [...]

The FDA plays a critical role in regulating medical devices, pharmaceuticals, and biologics, ensuring the safety and efficacy of healthcare products. However, with recent political shifts, leadership changes, and funding concerns, the regulatory landscape is [...]