In June 2025, the U.S. Food and Drug Administration (FDA) issued a long-anticipated draft guidance that clarifies the process for transferring ownership of 510(k) clearances. The document: “Transfer of a Premarket Notification (510(k)) Clearance” addresses [...]

On July 17, 2025, President Donald Trump issued an executive order granting 39 medical device sterilization facilities a two-year extension to comply with new ethylene oxide (EtO) emissions limits. This move follows months of industry [...]

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 [...]

The combination products sector is an exciting intersection of drugs, devices, and biologics, offering immense potential to revolutionize healthcare. However, with this potential comes a uniquely challenging regulatory environment. The complex landscape of global regulations [...]

With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for this significant regulatory shift. This updated regulation will replace the current [...]

The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination [...]