• 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 disinfectant, subsystem, water purification
Regulation Description Water purification system for hemodialysis.
Definition Disinfectant intended for reprocessing water purification systems for hemodialysis.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel General Hospital
Product CodeNIH
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(K) Exempt
Regulation Number 876.5665
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA intends to propose exempting these devices from premarket notification pursuant to the criteria at sections 510(l) and 510(m) of the FD&C Act, subject to limitations on exemption criteria found in .9 of the associated classification regulation. Until the publication of a final rule or order exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.
Recognized Consensus Standards
Guidance Documents
  • Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA
  • Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-