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Workshop on IVD Testing for Anticoagulants


Federal Register Notice: FDA will hold a public workshop 10/26 entitled “In Vitro Diagnostic Testing for Direct Oral Anticoagulants.” The workshop will gain public input and 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. The 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. The workshop will be held 10/26, from 9 a.m. to 5 p.m. at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD. Contact Claudia Dollins, (301) 796-4807, Claudia.Dollins@fda.hhs.gov. To view this notice, click here.