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U.S. Department of Health and Human Services

Product Classification

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Device pad, menstrual, reusable
Regulation Description Unscented menstrual pad.
Definition A reusable menstrual pad is made of cellulosic or synthetic material used to absorb menstrual fluid or other vaginal discharge.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeNUQ
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.5435
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff - Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s)
Third Party Review Not Third Party Eligible
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