FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and ...

FDA has just published a 101-page rule titled “ Medical Devices; Quality System Regulation Amendments,” finalizing the February 2022 proposed rule of the same name.

The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation ...

The US Food and Drug Administration (FDA) has granted 510 (k) clearance to PathAI for its digital pathology image management system, AISight Dx, to be used in primary diagnosis in clinical settings.

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...

The FDA's Quality Management System Regulation aligns U.S. standards with ISO 13485 for medical devices, promoting global consistency in quality management.

In short, FDA’s harmonization of its device quality management system regulations with ISO 13485:2016 will help to further the establishment of a global standard for device quality systems, but ...