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DDT COA #000037: Short Physical Performance Battery (SPPB)

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN)
Division of General Endocrinology (DGE)

DDT COA Number
DDT COA #000037

Instrument Name
Short Physical Performance Battery (SPPB)

Hip fracture

Concept of Interest
Lower-extremity functional decline

Context of Use
Adult patients (>65 years) who have diminished muscle mass, muscle strength and decreased function as a result of hip fracture

COA Type

Qualification Stage
Letter of Intent-Accepted

Aging in Motion Coalition of the Alliance for Aging Research

Ryne Carney
Jack Guralnik

Date Accepted into CDER’s COA Qualification Program
January 3, 2014

Submission and Regulatory Correspondence History

Qualification Submission


FDA Submission Decision & Recommendations



Transition Letter to 507 Process


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