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