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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 14-398
Standard
AOAC  6.3.05:2013
Official Method 966.04, Sporicidal Activity of Disinfectants Method I
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.6885 Sterilant, Medical Devices Class 2 MED
§880.6890 Disinfectant, Medical Devices Class 1 LRJ
Relevant FDA Guidance and/or Supportive Publications*
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers, Issued January 2000.

ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Yong Xue
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVC/
  --
  Yong.Xue@fda.hhs.gov
Standards Development Organization
AOAC AOAC International https://www.aoac.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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