Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

United States

Set Alert for Policy and Regulation United States

Payment 'Sunshine' Requirements Would Expand For Industry Under Senate-Passed Opioid Bill

A provision to expand Sunshine Act industry reporting requirements for companies in the Senate-passed “Opioid Crisis Response Act” has caught criticism from the device sector, despite overall industry support for the legislation.

Legislation Regulation United States
Advertisement

Latest From United States, Policy & Regulation

FDA Guidance Looks At Benefit Vs. Risk In Certain 510(k)s

A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions for substantially equivalent products with differing technological characteristics.

Medical Device Regulation

FDA's Speedy Apple Watch De Novos Raise Questions For Industry

The recent US FDA de novo approvals for heart-rhythm analysis software on Apple's latest Apple Watch, which took about 30 days from submission to a decision that aligned with Apple's high-profile launch event, raised eyebrows in the medtech industry. Some in industry are concerned that the tech giant received preferential treatment over smaller companies, setting a bad precedent. But some say it could be a positive sign for the digital health industry at large.

Digital Health Regulation

US Watchdog OKs Ortho Firm's Refund Plan

A device manufacturer wouldn’t violate anti-kickback law by offering hospitals a refund if their joint replacement fails for patients, the Department of Health & Human Services’ Office of the Inspector General said in a recent advisory opinion.

Compliance Policy

'The Sky's The Limit' When It Comes To Device Reimbursement Reforms, White House Official Says

The top health official at the White House Office of Management and Budget says the Trump administration is committed to clearing barriers that stand in the way of reimbursement for new medical technology. “We’re doing a lot of work on medical device stuff that nobody knows about, trying to figure out how America can maintain our dominance," Joe Grogan said Sept. 20.

Reimbursement Market Access

AdvaMed's Top Hill Strategist JC Scott Departs; Greg Crist Will Fill Role

Greg Crist, the top public affairs executive at AdvaMed, is stepping in to head the trade group's government affairs operations, as JC Scott departs to lead the Pharmaceutical Care Management Association.

Appointments Policy

House-Passed Tax Bill Would Support Medtech Innovation, Lobbyists Say

The device industry is praising passage of “The American Innovation Act” by the US House. The bill is intended to promote new business start-ups – including fledgling medtech companies – by allowing certain tax deductions for net-operating losses.

Legislation Policy
See All
UsernamePublicRestriction

Register