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U.S. Department of Health and Human Services

Product Classification
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Device system, transdermal delivery, cder or cber led
Definition Drug delivery systems designed to deliver at least one therapeutically active ingredient (drug substance) across the skin for systemic effect.
Physical State Drug delivery systems designed to deliver at least one therapeutically active ingredient (drug substance) across the skin for systemic effect.
Technical Method Drug delivery systems designed to deliver at least one therapeutically active ingredient (drug substance) across the skin for systemic effect.
Target Area Skin.
Review Panel General Hospital
Product CodeQIX
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Not Classified Reason Unknown
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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