DDT COA #000105: Actibelt® in Sarcopenia
Clinical Outcome Assessments (COA) Qualification Submissions
Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of General Endocrinology (DGE)
DDT COA Number
DDT COA #000105
Instrument Name
Actibelt® in Sarcopenia
Disease/Condition
Sarcopenia
Concept of Interest
change in real-world walking speed
Context of Use
Patients with sarcopenia in recovery after surgical treatment of hip fracture
COA Type
DHT- Passive Monitoring COA
Qualification Stage
Letter of Intent- Accepted
Requestor(s)
Martin Daumer
Contact(s)
Martin Daumer
Date Accepted into CDER’s COA Qualification Program
January 18, 2019
Submission and Regulatory Correspondence History
| Qualification Submission | Date | FDA Submission Decision & Recommendations | Date |
|---|---|---|---|
|
9/20/18 |
1/18/19 |