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United States

Set Alert for Policy and Regulation United States

Health Reform Roundtable Members Hold Conflicting Views On Device Tax Repeal For ACA Reform

A group of high-level health policy analysts – including former Medicare and Medicaid officials and experts at policy groups including Families USA and the American Enterprise Institute – have crafted a bipartisan recommendation for Affordable Care Act reform, but are divided on if the 2.3% device excise tax created by ACA should be repealed.

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

MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill

President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.

Policy Legislation

Expanding The Medtech Toolbox: US FDA's 'Medical Device Development Tools' Program Rolls Out

Three years in the making, FDA has released a final guidance for medical device development tools that would allow developers to qualify their MDDTs and give medical device manufactures access to new tools that could help them prove safety and effectiveness of their products sooner.

Regulation Clinical Trials

PMA Supplement Studies Weak, Study Finds, As Past FDA Chief Califf Calls For More Rigor

The quality of studies used to support panel-track PMA supplement approvals need upgrading, as fewer than half were randomized, blinded or controlled and many relied on surrogate endpoints, says a study published in JAMA. In an accompanying editorial, former FDA commissioner Robert Califf, says it "raises concerns" that the US regulatory system has gotten "too permissive."

Clinical Trials Regulation

Patrick Conway Departs CMS As It Diverges From His Vision

Conway, a champion of the US agency's move into value-based care, will take the helm at Blue Cross/Blue Shield of North Carolina.

Policy Medical Device

Could CMS Changes To Bundled Pay Models Stifle Medtechs' Value-Based Pay Plans?

The US Center for Medicare and Medicaid Services proposed downsizing its CJR joint replacement value-based payment model and outright canceling its cardiac procedure bundled payment model. Will the move discourage companies like Zimmer Biomet, Johnson & Johnson, and Medtronic, which have already invested in programs based on the value-based models?

Reimbursement Market Access

Senator Introduces Medical Device Cybersecurity Act

Sen. Richard Blumenthal, D-Conn., recently introduced legislation that would enhance medical device security by generating a "cyber report card" for medtech products and securing more remote access protections for devices in hospitals. S. 1656 draws on advice in a June 2 HHS white paper on improving cybersecurity in the health-care industry.

Cybersecurity Policy
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Latest From United States & Quality Control

US FDA Maturity Model Pilot Program Gets October Meeting Date

The agency wants to hear public feedback on its plan to employ a standardized model to measure a company's manufacturing "maturity" via third-party assessments to support regulatory and compliance decisions.

Quality Control Compliance

Zimmer: Surprised By Biomet Quality Problems, But Responded Before FDA Arrived

Zimmer Biomet's response to a US FDA Form-483 says the firm was unaware of the quality systems woes at the targeted Biomet Warsaw, Ind., plant before its 2015 acquisition of the company. But, it emphasized, comprehensive fixes were in the works even before the 2016 agency inspection that generated more than a dozen substantive observations took place.

Quality Control Compliance

More Review-Streamliners Introduced In US House: Can They Beat User-Fee Buzzer?

Two more bills were introduced in the House this week to streamline US FDA device review. Its late in the game, but device lobbyists are not completely ruling out attachments to must-pass user-fee bills. Also, check out our table rounding up FDA medtech reform bills that are circulating in Congress.

Legislation Policy
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