A medical device user fee reauthorization bill was approved June 21 by the House Energy and Commerce Committee and cleared for floor debate. The legislation largely mirrors proposals previously negotiated by industry and FDA, with some additional amendments addressing postmarket safety concerns (see chart: "1Selected User Fee Bill Amendments From House Energy and Commerce Committee:")
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The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.
