DDT COA #000103: ActiMyo®
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology I (DN I)
DDT COA Number
DDT COA #000103
Instrument Name
ActiMyo®
Disease/Condition
Duchenne Muscular Dystrophy (DMD)
Concept of Interest
Daily motor activity
Context of Use
Children, adolescent, and adult patients (> 5 years old) with DMD
COA Type
DHT- Passive Monitoring COA
Qualification Stage
Letter of Intent - Accepted
Requestor(s)
Sysnav
Contact(s)
Marc Grelet
Date Accepted into CDER’s COA Qualification Program
August 30, 2018
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
| Letter of Intent | 9/21/17 | FDA Response (Accepted) | 8/30/18 |