Rotation Medical Inc.’s implantable collagen scaffold induces formation of new tendon-like tissue, and in some cases eliminates the need for suture anchors in surgical repair. This new technique has the potential to prevent rotator cuff disease progression and significantly reduce the incidence of re-tears.
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HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
