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