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Those who work with laboratory developed tests (LDT) would have much preferred their rapidly developing field be regulated by the Verifying Accurate, Leading-edge IVCT Development (VALID) Act — but since Congress has repeatedly failed to pass the bipartisan act, the field is now reeling at the “overreach” of the FDA’s new proposed rule on regulating LDTs. Read More
This edition of Quick Notes reviews Becton Dickinson’s increase in U.S. manufacturing of syringes, clearance of the twiist Automated Insulin Delivery system, a new indication for Amplify standalone bone graft putty, and Fujifilm’s AI-powered endoscopic imaging technology. Read More
Three plastic syringe makers have received FDA warning letters describing violations related to the sale and distribution of plastic syringes made in China that have not been cleared or approved for sale or distribution in the U.S. Read More
Devicemakers considering how to comply with the recently released Quality Management System Regulation (QMSR) will need to keep on hand a copy of the international standard ISO 13485 — the copyright-protected document that’s included only by reference in the new regulation. Read More
Within the supply chain universe, medical technology and its countless components needs to stay front and center when competing with other industries, emphasized the FDA’s lead officer on the subject during a two-day workshop on generic drug-device combination products last week. Read More
Four units within the FDA have worked together to publish a paper to provide greater transparency on how they will collaborate with the pharmaceutical industry as it develops and deploys AI technologies. Read More