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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 5-133
Standard
ISO 80369-7 Second edition 2021-03
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Scope/Abstract
This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.
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.
Transition Period
FDA recognition of ISO 80369-7 First edition 2016-10-15 Corrected version 2016-12-01 [Rec# 5-115] will be superseded by recognition of ISO 80369-7 Second edition 2021-03 [Rec# 5-133]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 5-115] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 5-115] will not be accepted.

FDA recognition of ISO 594-1 First edition 1986-06-15 [Rec# 6-11] and ISO 594-2 Second edition 1998-09-01 [Rec# 6-129] will be superseded by recognition of ISO 80369-7 Second edition 2021-03 [Rec# 5-133]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-11] and [Rec# 6-129] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 6-11] and [Rec# 6-129] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Syringe, Piston Class 2 FMF
Relevant FDA Guidance and/or Supportive Publications*
1. Guidance On The Content Of Premarket Notification [510(K)] Submissions For Hypodermic Single Lumen Needles. Issued April 1993

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

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

4. 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/OC/CDRH/OSPTI/DAHRSSP/SCAP/
  301-796-6287
  scott.colburn@fda.hhs.gov
 Keith Marin
  FDA/OC/CDRH/OPEQ/OIDRH/
  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)
*These are provided as examples and others may be applicable.
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