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US Congress successfully pushed through a user-fee bill in 2017 to help smooth the regulatory path at FDA for medical devices and other products, but other efforts, including several industry priorities, remain undone. On top on the list, of course, is the effort to repeal the device excise tax. But legislation is also on the table to address diagnostics regulation, telehealth reimbursement, and medtech cybersecurity vulnerability, among other issues. Here is a look at the medtech landscape in Congress in 2018.
Latest From United States, Policy & Regulation
FDA and the US Department of Defense launched program to prioritize development of medical products for use in the battlefield. The program implements recently enacted compromise legislation that resolved a turf battle between the two agencies.
The agency slowed down its effort to require the overwhelming majority of medical devices to adopt Unique Device Identifiers with a a new guidance that would in delay full implementation of the UDI system for lower-risk devices.
A proposed coverage policy from the US Centers of Medicare and Medicaid Services would not only cover magnetic resonance imaging for patients with an implanted cardiac rhythm management device with an FDA-approved indication for MRI-compatibility, but will also cover MRI in patients with devices without that FDA labeling in certain circumstances.
Starting out 2018, Scott Gottlieb issued a new directive to US FDA staff outlining his priorities and vision. Among the directives is to promote digital health and diagnostics by creating efficient pathways for new products in the areas and focusing on technology to help consumers better track their health.
On this week’s podcast, Medtech Insight’s Sue Darcey and Shawn M. Schmitt discuss an intriguing analysis of legislation that could be completed in 2018 that will likely impact the medtech industry.
In a sign of the times, the Medical Imaging & Technology Alliance, a major medtech trade organization in Washington, DC, has established a new director position on cybersecurity and has hired someone to fill it. Zack Hornberger will lead MITA's efforts to develop positions on cybersecurity policy and standards.
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