CDRH Industry: Public Workshop - In Vitro Diagnostic Testing for Direct Oral Anticoagulants, October 26, 2015

The Food and Drug Administration (FDA) is announcing a public workshop titled “In Vitro Diagnostic Testing for Direct Oral Anticoagulants” scheduled for October 26, 2015. The objective of the workshop is to discuss analytical performance requirements for the diagnostic assessment of direct oral anticoagulants (DOACs), and the clinical circumstances under which patients receiving these agents would require testing. Specifically, this workshop aims to 1) evaluate the impact of DOACs on traditional coagulation testing results; 2) identify clinical circumstances where testing of DOACs anticoagulant activity or concentration would be relevant; 3) discuss clinically meaningful interpretation of coagulation testing results for patients on DOACs; and 4) review the regulatory requirements for granting clearance for in vitro diagnostic devices intended for coagulation testing in patients treated with DOACs.

For registration and additional information, please see: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm459448.htm