Medtech Year in Review: Device Tax, UDI, Budget Woes Top Concerns

Devices & Diagnostics Letter
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Devicemakers faced myriad challenges in 2013, as new rules and practices went into effect under the Affordable Care Act, FDASIA and the Physician Payment Sunshine Act. FDA offered guidance on a number of issues, including IVDs for research use only, medical device development tools and priority reviews. Globally, the year saw a steady push toward enactment of new device regulations in the EU, clampdowns on industry bribes in China and Brazil, and strict clinical trial compensation rules in India, to name just a few key developments. Here are 10 issues that kept industry buzzing this year. Use this list to review your regulatory program and prepare a successful business strategy for 2014.

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