U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Drug Development Tool (DDT) Qualification Programs
  5. Clinical Outcome Assessment (COA) Qualification Program
  6. DDT COA #000120: Scratch Sensor
  1. Clinical Outcome Assessment (COA) Qualification Program

DDT COA #000120: Scratch Sensor

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Immunology and Inflammation (OII)
Division of Dermatology and Dentistry (DDD)

DDT COA Number
DDT COA #000120

Instrument Name
Scratch Sensor

Disease/Condition
Atopic dermatitis

Concept of Interest
Itch intensity and persistence

Context of Use
Patients > 2 years with atopic dermatitis

COA Type
DHT- Passive Monitoring COA

Qualification Stage
Letter of Intent-Accepted

Requestor(s)
Steve Xu

Contact(s)
Steve Xu

Date Accepted into CDER’s COA Qualification Program
December 26, 2020

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent 9/12/19 FDA Response (Accepted) 1/7/20
Back to Top