DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Mobile Imaging
SEARCH
Current Location:
>
>
> This Story

Forward Printable StoryPrint Comment

 

 

U.S. Healthcare Homepage

Navidea Biopharmaceuticals receives noncompliance notice from NYSE American

ViewRay announces pricing of public offering of common stock

Change Healthcare blends artificial and human intelligence for Medicare Advantage dual eligibility and enrollment

Prime Healthcare resolves Department of Justice lawsuit

RSNA launches artificial intelligence initiatives

Senator Alexander calls for reduced administrative burden on doctors and hospitals to lower healthcare costs

Influence of dense breast notification and insurance legislation on downstream breast ultrasound

Medtech industry readies Senate push for full device tax repeal

Guerbet announces AHRA charitable contribution to support next generation leaders in medical imaging

NEMA urges administration to minimize collateral damage from tariffs

AdvaMedDx applauds Hill's release of FDA’s technical assistance for legislation to modernize regulation of clinical diagnostics

Press releases may be edited for formatting or style
Washington, D.C. – AdvaMedDx applauds Capitol Hill's release of technical assistance (TA) developed by the Food and Drug Administration (FDA) to draft legislation authored by Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) as a significant, positive step toward enacting legislation modernizing regulation of all diagnostics, including Laboratory Developed Tests (LDTs).

AdvaMedDx has long supported FDA oversight of all diagnostics, including LDTs, under a risk-based approach that promotes the public health and innovation.

Story Continues Below Advertisement

Servicing GE Nuclear Medicine equipment with OEM trained engineers

We offer full service contracts, PM contracts, rapid response, time and material,camera relocation. Nuclear medicine equipment service provider since 1975. Click or call now for more information 800 96 NUMED



“Innovative medical diagnostic tests and technologies are the foundation for evidence-based medicine, allowing for early intervention that improves patients' health outcomes, often lowering costs for the broader health system. The FDA’s technical assistance in support of a modernized and predictable, regulatory framework for all diagnostic tests, will allow further progress on Capitol Hill toward enacting legislation to speed the pace and reach of cutting edge diagnostics, allowing patients to benefit more broadly, rapidly, and confidently, from the latest diagnostic technologies," said Susan Van Meter, Executive Director of AdvaMedDx.

Over the past several years FDA has made strides to improve the regulatory process for diagnostics through flexible, efficient approaches to help pave the way for new advances, including personalized medicine. This TA is a step forward in efforts to advance a risk based approach to regulation of clinical diagnostics that promotes the public health and innovation.

Today AdvaMedDx joined several patient groups, laboratory and provider associations in sending a letter to the Chairmen and Ranking members of the Senate Committee on Health, Education, Labor & Pensions (HELP) and House Energy and Commerce Committee, appreciating the release of the FDA’s TA as an important and necessary next step in the pursuit of comprehensive legislative reform. We urge Congress to move swiftly to enact comprehensive diagnostics regulatory reform legislation. To view the full letter, click here.

“As we review the TA released by the FDA, we look forward to continuing to work with Congress, the FDA, and the broad range of stakeholders with whom we share the goal of making diagnostics reform a reality,” said Van Meter.


About AdvaMedDx
AdvaMedDx member companies produce innovative, high quality in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, promote wellness, enable early detection of disease and can reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is dedicated to the issues facing in vitro diagnostic companies in the United States and abroad.

Back to HCB News
  Pages: 1

U.S. Healthcare Homepage


You Must Be Logged In To Post A Comment

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2018 DOTmed.com, Inc.
ALL RIGHTS RESERVED