News

February 4, 2015

AAB and NILA Release Comments on FDA's Draft Guidances on LDTs

Click below to download and read AAB and NILAs comments and the FDA's draft guidances:

NILA/AAB Press Release on LDTs 

Click to view AAB/NILA's comments 

Click below to view the FDA's draft guidances (10/3/14):

Framework for Regulatory Oversight of LDTs 

Notification and Medical Device Reporting for LDTs 

NILA News

5/24/2024
FDA Publishes Proposed Enforcement Policies for Tests During a Declared Emergency

5/6/2024
Final Rule on LDTs officially published in Federal Register

4/29/2024
NILA and American Association of Bioanalysts (AAB) Respond to FDA's Release of Final Rule on LDTs

Laboratory Outreach Communications System (LOCS)

Click here for laboratory-related information and communications from the Centers for Disease Control and Prevention (CDC).