The Food and Drug Administration (FDA) is the regulatory body governing medical devices with a variety of enforcement tools at its disposal, such as seizure, injunction, prosecution and civil penalties.
This brief serves as a quick guide for the FIME audience on how and where to submit an application, as well as information about device classification, required documentation, approval processes, and application fees, among others.
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The medical device industry is keeping a close eye on the relationship between the United States and its immediate neighbor to the south. The countries reached a deal to indefinitely suspend proposed tariffs after the U.S. announced earlier this year that it would impose a 5% tariff, eventually set to rise to 25%, on all imports from Mexico, including medical devices.
The United States relies on Mexico for 17% of its medical device imports. It could potentially be devastating to the medical device industry and, ultimately, to patients.
Read more about tariffs on medical devices in this report.
However, many requirements need to be met to make these endeavors a success.
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Check out the key figures, trends for 2019 and see how the future of innovation on healthcare can affect your business goals.
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The medical device excise tax is scheduled to restart in January after being suspended for the last four years (for two consecutive two-year periods). Will the industry's renewed lobbying efforts get the tax repealed once and for all?
US spends 17.8% of GDP - this is the highest percentage in the world. The global average is just 6.8%.
Check the overview of market forces, key trends, healthcare spending and other factors affecting the US and Latin American healthcare marketplace.
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The refurbished medical equipment market contributes to grand societal challenges by reducing waste and conserving resources; increasing access to healthcare in markets with increasing healthcare cost pressure; and offering economic benefits from extending the life cycle value of manufactured equipment and creating new jobs, growth and investment.
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