| 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
|
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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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, Piston
|
Class 2
|
FMF
|
| §880.5860 |
Syringe, Antistick
|
Class 2
|
MEG
|
|
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. |
