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 ...

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

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 ...

Aside from the key points outlined in the warning letter, the FDA claimed that Nuowei “does not operate an effective quality system” and called on the company’s management to “immediately ...

Glenmark’s backlogged testing “was overdue by 3 months or longer for a large proportion of your samples,” the FDA wrote in ...