My IDSA Contact Us
IDSA NewsPrint-Friendly Newsletter
Forward to a Friend
Search Back Issues
Education & Training Resources Practice Guidelines Journals & Publications Policy & Advocacy Meetings About IDSA
March 2015
Laboratory Developed Tests: Regulation Should Keep Pace With ID Patient Needs

IDSA submitted comments to the Food and Drug Administration (FDA) in response to its draft guidance to regulate laboratory developed tests (LDTs), diagnostic devices intended for clinical use that are designed, manufactured, and used within a single laboratory.  IDSA agrees that oversight of LDTs may be appropriate; however, the Society expressed concern that some elements of the regulations could limit patient access to ID testing and provided specific recommendations to address these key issues.  

Diagnostic Task Force member Gregory A. Storch, MD, FIDSA, served on a panel discussion at an FDA public workshop on the regulations, while IDSA staff provided public comments on the regulations. 

IDSA also drafted a response to several questions posed by the House Energy and Commerce Committee about the proposed LDT regulation as well as incentives for diagnostic development.  IDSA stressed the importance of infectious disease diagnostics in patient care, and the need for flexible regulations to allow innovative test development to keep pace with evolving and emerging infectious diseases.

< Previous Article | Next Article >

Post a comment

Your name:

Your comment:

Public Comment Period for IDSA/AAN/ACR Lyme Guideline Project Plan Closes April 9
FDA Approves New Drugs, Cresemba and Avycaz
NIH Training Opportunity: Biosafety Officer in High-Containment Facility
IDSA Joins the “Choosing Wisely” Campaign to Cut Back on Unnecessary Medical Care
New Forum for Contracting and Negotiations Information Exchange
IDSA Advances Priorities in 21st Century Cures Legislation
HIVMA Receives CAEAR Coalition Partnership Award
New Statement on Criminalization of HIV and other Communicable Diseases
ID Funding Highlighted on Capitol Hill
Laboratory Developed Tests: Regulation Should Keep Pace With ID Patient Needs
IDSA Responds to NIH on Proposed Regulatory Process for Multi-Site Research Trials
NIAID Launches ClinRegs Website on International Clinical Research Regulations
Science Speaks: Coverage of CROI 2015
Education and Resources
ABIM MOC Changes
Free IDSA Hepatitis C MOC Module
IDSA to Offer Infection Control MOC Pre-Meeting Workshop at SHEA Spring Meeting
OFID is Now Indexed in PMC
Apply Now for IDSA Fellow Advancement
IDSA Begins Search for CID Editor-in-Chief
Members on the Move
New Members
From the President
Regaining Ground on Measles Eradication: The Role of the ID Specialist
Top Stories
Clinicians: Here’s How to Avoid a Payment Penalty in 2017
IDWeek Advance Registration Now Open for IDSA Members
IDSA Journal Club
IDSA | 1300 Wilson Blvd., Suite 300 | Arlington, VA 22209 | Phone: (703) 299-0200
To ensure delivery, please add '' to your email address book or Safe Sender List.
If you are still having problems receiving our communications,
see our white-listing page for more details.