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 [...]

With the February 2, 2026, implementation date for FDA’s Quality Management System Regulation (QMSR) quickly approaching, FDA has now issued a final rule making 179 technical amendments across Title 21 of the Code of Federal [...]

The U.S. government shutdown has finally ended, and for the FDA, the relief is real. With Congress passing a funding bill covering the agency through September 30 of the next fiscal year, the agency now [...]

The FDA’s updated guidance on Unique Device Identification (UDI) for combination products, updated as of June 2025, has stirred conversation across the industry. For companies developing products that merge drug, biologic, and device components, labeling [...]

The start of October 2025 brought an unusual complication for the life sciences industry - a partial U.S. government shutdown that has significantly limited FDA operations. With much of the agency’s staff on furlough and [...]

The FDA issued a new guidance on the use of “alternative tools” for assessing manufacturing facilities as part of the drug and biologics approval process. This guidance, titled "Alternative Tools for Assessing Manufacturing Facilities Named [...]