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

Senate Panel Passes Breakthrough Device, Other Measures; FDA Funding Debated

This article was originally published in The Gray Sheet

Executive Summary

The Senate HELP Committee voted March 9 in favor of a breakthrough device provision, watered down from a version approved in the House last year. Other bills voted out of committee include a combination products reform measure, the digital-health focused MEDTECH Act, and four others. Senators are still debating whether NIH and FDA should get additional funds to cover the cost of the bills, which will be wrapped up into a broader package before Senate floor debate.

Advertisement

Related Content

House Set To Vote On Cures Nov. 30; Latest Version Includes 510(k)s In Breakthrough Pathway
FDA Funding Debate Reframed By GAO Reports On Strategic Planning
CDRH's Expedited Access Pathway: 17 Devices And Counting
Senate Moves To Floor Phase For Innovation Bill; Postmarket Surveillance, LDTs Could Get Attention
Senate Will Tackle Separate Device Reform Bills As Part Of Innovation Agenda
2016 Will Be A Big Year For Combo Product Reform, FDA Says
Senate Bill Aimed At Streamlining Combo Product Regulation
'Cures' Bill Passes, As More Budget, Safety Debates Wait In The Wings
Shortened ‘Cures’ Draft Retains Breakthrough Pathway, Device Reforms
Three Next-Gen Prosthetics Projects To Receive BRAIN Funding

Topics

Advertisement
UsernamePublicRestriction

Register

MT034588

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel