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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Recognition 07/15/2019 
FR Recognition Number 5-115
Standard
ISO 80369-7 First edition 2016-10-15
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
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
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Syringe, Piston Class 2 FMF
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
Relevant FDA Guidance and/or Supportive Publications
Guidance On The Content Of Premarket Notification [510(K)] Submissions For Hypodermic Single Lumen Needles. Issued April 1993

Guidance On The Content Of Premarket Notification [510(K)] Submissions For Piston Syringes. Issued April 1993

Guidance For Industry And FDA Staff Medical Devices With Sharps Injury Prevention Features. Issued August 9, 2005

(Website) Information for Manufacturers of Small-Bore Connectors and Medical Devices with Connectors
http://www.fda.gov/medicaldevices/safety/alertsandnotices/tubingandluermisconnections/ucm313322.htm
FDA Technical Contacts
 Scott A. Colburn
  FDA/OMPT/CDRH/OCD/
  301-796-6287
  scott.colburn@fda.hhs.gov
 Keith Marin
  FDA/OMPT/CDRH/ODE/DAGID/GHDB/
  301-796-2462
  keith.marin@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
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