Abstract
Get full access to this article
View all access options for this article.
References
1.Centers for Medicare and Medicaid Services (2015 ) Clinical Laboratory Improvement Amendments (CLIA) . Accessed on July 15 , 2015
2.Energy and Commerce Committee (2014 ) 21st Century Cures—Request for Feedback: A Modernized Framework for Innovative Diagnostic Tests. United States House of Representatives, Chairman Fred Upton . Accessed on June 12 , 2015
3.Energy and Commerce Committee (2015 ) 114th Congress, 1st Session, 21st Century Cures Bill [Draft] . Accessed on July 17 , 2015
4.Energy and Commerce Committee (n.d.) Respondents to 21st Century Cures—Request for Feedback: A Modernized Framework for Innovative Diagnostic Tests . Accessed on June 15 , 2015
5.
Gaffney
A
(2015 ) Regulatory Explainer: The (Updated) 21st Century Cures Act. Regulatory Affairs Professional Society . Accessed on July 17 , 2015
6.
Ray
T
(2015 ) Draft of 21st Century Cures Legislation Addresses Device Reforms, but Silent on LDTs. GenomeWeb . Accessed on July 17 , 2015
7.
Shuren
J
,
Conway
PH
2015 ) FDA and CMS Form Task Force on LDT Quality Requirements. U.S. Food and Drug Administration . Accessed on July 15 , 2015