DDT COA #000053: Symbol Digit Modalities Test (SDMT)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology II (DN II)

DDT COA Number
DDT COA #000053

Instrument Name
Symbol Digit Modalities Test (SDMT)

Disease/Condition
Multiple Sclerosis (MS)

Concept of Interest
Processing speed

Context of Use
Adults with a diagnosis of MS and a relapsing-remitting (RRMS), secondary progressive (SPMS), or primary progressive (PPMS) clinical course

COA Type
PerfO

Qualification Stage
Qualification Plan- Accepted

Requestor(s)
Critical Path Institute
Multiple Sclerosis Outcome Assessments Consortium (MSOAC)

Contact(s)
Lynn Hudson

Date Accepted into CDER’s COA Qualification Program
December 23, 2013

Submission and Regulatory Correspondence History

Qualification Submission	Date	FDA Submission Decision & Recommendations	Date
--	--	Transition Letter to 507 Process	8/27/19
Qualification Plan- Accepted	2/27/20	FDA Response (Accepted)	4/27/20