United States remains an interesting market with a great potential for the medical sector.

The latest data are still in line with a well-tested trend: the country is the world’s largest medical device market and there is evidence suggesting no slowdown in this trend. In 2016 the Medical Devices sector was estimated at about $ 150 billion and further data are expected to grow at least until 2019.

Market opportunities are now well known to companies in the industry: populations with great aging prospects, record numbers associated with chronic diseases and the 2010 law on patient protection that should increase access to health services for all people previously excluded. Not to mention that the market requests cost-effective Medical Devices to meet the growing demand for medical care, respecting the new healthcare system cost constraints, also managing to control the increase in healthcare expenditure.

Despite the good premises, Trump’s presidency may have a negative impact on the perception of foreign stakeholders in the American market.

For example, the news that President Trump included in the 2018 budget proposal almost $ 1 billion increase in FDA fees for submitting applications or meeting regulatory compliance was certainly not welcomed.

President Trump also included the abrogation and replacement of the so-called “Obamacare” in its agenda, but it is still unclear how he will proceed.

If from an administrative and political point of view the approach is cautious and there are many uncertainties, from a regulatory point of view the FDA does not miss the opportunity to launch updates and monitor the system.

For example, the Class II Medical Devices exempt from pre-market requirements 510(k) definitive list was published on July 11, 2017. The final list includes more than 1,000 Class II devices, which will reduce the regulatory constraints as well as eliminate the costs and expenses required by the FDA.

Other changes are scheduled for October and the electronic Medical Device Reporting System (eMDR) updating activities are in progress. It is useful to remember that this system was set up in 2014 when the FDA issued a guidance requiring manufacturers and importers to submit electronic reporting of adverse events and product-related issues. Recent changes include device identification data (UDI), formatting requirements, borderline devices and codes identifying device issues.

Finally, it is worth mentioning the projects for digital health technologies regulation: the CDRH intends to develop digital health technologies through the publication of some guidances for medical software, applications to be used in the medical field as well as Medical Devices intended to store images and communicate data.


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