DDT COA #000129: Advanced Gait Analysis
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology I (DN I)
DDT COA Number
DDT COA #000129
Instrument Name
Advanced Gait Analysis
Disease/Condition
Huntington’s Disease
Concept of Interest
Progressive gait abnormality
Context of Use
Ambulatory adults with pathogenic genetic mutation and CAG expansion indicative of HD
COA Type
DHT- Passive Monitoring COA
Qualification Stage
Letter of Intent - Not Accepted
Requestor(s)
MC10, Inc
Contact(s)
Kathryn Nolan
Date Accepted into CDER’s COA Qualification Program
n/a
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Letter of Intent | 4/13/20 | FDA Response (Not Accepted) | 6/5/20 |