DDT COA #000090: Facioscapulohumeral Composite Functional Outcome Measure (FSHD-COM)

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

DDT COA Number
DDT COA #000090

Instrument Name
Facioscapulohumeral Composite Functional Outcome Measure (FSHD-COM)

Disease/Condition
Facioscapulohumeral muscular dystrophy (FSHD)

Concept of Interest
Physical functioning

Context of Use
Patients with FSHD

COA Type
PerfO

Qualification Stage
Letter of Intent - Not Accepted

Requestor(s)
Jeffrey Statland

Contact(s)
Jeffrey Statland
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	11/20/17	FDA Response (Not Accepted)	8/30/18