Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Senate HELP Advances Device Review Reform Bills

This article was originally published in The Gray Sheet

Executive Summary

The Senate Health, Education, Labor and Pensions Committee approved a slate of bills Feb. 9, including the Device Accountability Act, which enhances focus on the "least burdensome" concept for device review, and legislation intended to improve oversight of modified devices and device reprocessing.

You may also be interested in...



Wyden 2017 Chronic-Care Bill Would Reward Telemedicine, Home-Use Devices

Sen. Ron Wyden, D-Ore., ranking member of the Senate Finance Committee, plans to reintroduce chronic-care legislation in 2017 that would lead to more Medicare reimbursement of home-use devices and telemedicine options for elderly patients with multiple conditions.

Sen. Murray Prods FDA To Clarify 510(k) Modification Policies In Superbug Bill

Following up on recommendations made in her January report on duodenoscope contamination, Senate HELP Ranking Member Patty Murray, D-Wash., introduced a bill pressing FDA to accelerate its work to clarify when 510(k)s are needed for device modifications and to solidify the agency's authority to deny submissions if the sponsor fails to provide validated reprocessing data.

Senate Will Tackle Separate Device Reform Bills As Part Of Innovation Agenda

Multiple bills focused on accelerating the path to market for devices will join safety legislation reforming the regulation of duodenoscopes in a slate of Senate bills that HELP Committee Chairman Lamar Alexander said will receive hearings in February, March and April. The legislation-by-legislation approach in the Senate differs from the broad-based 21st Century Cures package that advanced in the House.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034963

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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