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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 053 Date of Entry 12/23/2019 
FR Recognition Number 6-437
Standard
ISO  23907-2 First edition 2019-11
Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.
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
§880.5570 Container, Sharps Class 2 MMK
Relevant FDA Guidance and/or Supportive Publications*
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers, Issued October 1993.

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 Contacts
 Elaine Mayhall
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-6301
  Elaine.Mayhall@fda.hhs.gov
 Matthew Schwerin
  FDA/OC/CDRH/OSEL/DAM/
  301-563-9114
  matthew.schwerin@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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