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The FDA’s newest draft guidance addresses premarket submission requirements for Class II and III implantable orthopedic devices coated with metals, calcium phosphate, or a combination of those materials. Read More
This edition of Quick Notes looks at the FDA approving devices and systems that detect and/or offer treatment for potential skin cancer, Alzheimer’s, lung fibrosis and diabetic neuropathy. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
CMS and the FDA have issued a rare joint statement advocating for the oversight of laboratory developed tests (LDT) by both agencies, rather than keeping it solely within CMS. Read More
Inspections will be much more streamlined once the FDA completes its sweeping reorganization, according to Deputy Commissioner Janet Woodcock. Read More
Federal watchdog the General Accounting Office (GAO) will be investigating the FDA and its oversight of medical device recalls, highlighted by health crises related to Philips Respironics’ ventilators and CPAP devices. Read More
Over the past week, the FDA issued final guidance on drug security at the package level and announced a meeting of the medical imaging drugs advisory committee. Read More