WASHINGTON, Nov. 18, 2016 /PRNewswire-USNewswire/ -- The American Clinical Laboratory Association (ACLA) applauded today'sannouncement by the Food and Drug Administration (FDA) that it will not release a final guidance to regulate laboratory developed tests and instead work with Congress and other stakeholders to determine the best solution to reform.
In response to the FDA's efforts to use the agency's medical device authority to regulate LDTs, ACLA has consistently maintained that LDTs are not medical devices and cannot be regulated as such.
"Today's announcement by the FDA has paved the way for a transparent discussion on meaningful reform that would protect diagnostic innovation and patient access," concluded Mertz. "The clinical laboratory community looks forward to working with all stakeholders as diagnostic innovation continues to be front and center in the advancement of medical science."
About the American Clinical Laboratory AssociationThe American Clinical Laboratory Association (ACLA) is a not-for-profit association representing the nation's leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.
Contact: Rebecca Reid(410) 212-3843
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/acla-commends-fda-decision-not-to-release-final-ldt-guidance-looks-forward-to-continuing-to-work-with-congress-and-the-incoming-administration-on-reform-that-puts-patients-first-300366066.html
SOURCE American Clinical Laboratory Association (ACLA)
Subscribe to our Free Newsletters!
Fallopian tube cancer is a form of gynecologic cancer arising in the fallopian tubes, which are ...
Cushing syndrome is a collection of symptoms caused due to excessive amount of cortisol in the body ...
CAR T-cell therapy is a type of gene therapy where the patient's T-lymphocytes are genetically ...View All