Regulatory & Reimbursement
FDA Output August 2019
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, and Warning Letters in August 2019.
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Regulatory & Reimbursement
Eye on the EU MDR: New Commission Leaders Prepare to Step In, with Eight Months To Go
Providers & Payors
Brazil Steps Forward on Implant Price-Monitoring Plan
Regulatory & Reimbursement
FDA Attempted to Ease Reporting Timeframes for Medical Device Reporting Requirements–Did it Succeed?
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Regulatory & Reimbursement
FDA Output August 2019
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, and Warning Letters in August 2019.
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Business Strategies
Jeff Shuren, 10 Years in at CDRH, Wants More Space to Innovate
Market Pathways checked in with Jeff Shuren as he approaches his decade mark at the FDA’s Center for Devices and Radiological Health. The longest-serving director in the center’s history, Shuren has so far left a vast and lasting footprint on how devices are regulated in the US. But he pines for a more untethered CDRH that can nimbly adapt itself to the rapidly evolving technology landscape.
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