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 [...]

Recently, Michael Kuehne at ComplyFDA conducted a deep dive into developing a baseline assessment using a risk-based approach looking at all quality processes. This approach delivers actionable improvement recommendations and incorporates validated best practices to [...]

“It’s a full thickness tear of your right rotator cuff.” Not words I ever wanted to hear, let alone leading up to a holiday. But this diagnosis gave me the opportunity to consider the safety [...]