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United States

Set Alert for Policy and Regulation United States

AdvaMed Making Push For Device Tax Repeal In Lame Duck Session

The "lame duck" session of Congress before newly elected members take their seats in January may be the best shot available for the device industry to win permanent device tax repeal, lobby group AdvaMed says. The group is making a major effort to repeal the tax before the new Congress takes over.

Legislation Policy Medical Device
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Latest From United States, Policy & Regulation

US FDA Allows Waiver Of Informed Consent For Clinical Investigations With Minimal Risk

The agency seeks input on the types of qualifying investigations that involve minimal risk. Providing informed consent waivers in these cases, as required by the 21st Century Cures Act, will help advance health-care innovations, FDA says.

Medical Device Clinical Trials

Device Week, Nov. 9, 2018 – What The US Midterms Mean For Medtech

On this week's podcast, David Filmore and Ferdous Al-Faruque discuss the results of this week's midterm elections in the US and what it could mean for the medtech sector.

Device Week Elections

NEST Test Cases Could Support Company Submissions And Determine Future Of National Device Database

Recently announced US National Evaluation System for health Technology "test cases" will be evaluated for up to a year by the NEST Coordinating Center after which collaborating device-makers may be in a better position to use real-world evidence to support new pre-market device submissions. The test cases will be measured, in part, based on their ability to identify brand-specific devices in the NEST Network Collaborators’ real-world datasets.

Clinical Trials Health Technology Assessment

3 Big Medtech Takeaways From US Midterms

The balance of power will be shifting in Washington, DC, following the Nov. 6 US midterm elections, but that probably will not mean major changes for medtech policies. Here are some key takeaways from the election for device and diagnostics companies.

Elections Legislation

US Midterms: Industry Loses Some Supporters In Congress, But Retains Many

With most of the Nov. 6 election tally completed, it’s clear there will be many new faces for the device industry to engage with in the halls of Congress, but the sector still appears to have a significant group of supporters on Capitol Hill. Also, several medtech-relevant measures were on the ballot.

Elections Legislation

Medicare Allows Use Of Hospital Outreach Lab Pay Data; Industry Applauds, But Still Sues

The clinical laboratory industry praised the US Centers for Medicare and Medicaid Services for making changes in its final Clinical Laboratory Fee Schedule rule to allow more data from hospital outreach labs to be considered in setting laboratory test pay rates. But lab advocates are still pursuing a lawsuit and pushing for legislative reforms.

Reimbursement Regulation
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