Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
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 Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
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
-
-