| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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055
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Date of Entry 12/21/2020
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FR Recognition Number
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5-133
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| Standard | |
ISO 80369-7 Second edition 2021-05
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications |
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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. |
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| Extent of Recognition
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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. |
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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FDA recognition of ISO 80369-7 First edition 2016-10-15 Corrected version 2016-12-01 [Rec# 5-115] will be superseded by recognition of ISO 80369-7 Second edition 2021-05 [Rec# 5-133].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of ISO 594-1 First edition 1986-06-15 [Rec# 6-11] and ISO 594-2 Second edition 1998-09-01 [Rec# 6-129] will be superseded by recognition of ISO 80369-7 Second edition 2021-05 [Rec# 5-133].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. |
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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 |
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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. (Website) Medical Device Connectors: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/medical-device-connectors
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
