Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

Regulators are analyzing whether long-term changes are needed for Boeing 737 MAX/CFM International Leap 1B load reduction devices. Credit: Kevin Carter/Getty Images European and U.S. regulators have ...

The NTSB is urging the FAA to ensure flight crews are aware of risks posed by a CFM International Leap-1B safety device that can cause smoke in the cockpit and wants an in-progress software ...