Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
031
|
Date of Entry 08/06/2013
|
FR Recognition Number
|
6-294
|
Standard | |
ISO 11608-3 Second edition 2012-10-01 Needle based injection systems for medical use - Requirements and test methods - Part 3: Finished containers |
|
Scope/AbstractThis part of ISO 11608 is applicable to containers that are provided pre-filled, or that are to be filled by the user with medicinal products intended by the manufacturer to be used with needle-based injection systems (NIS), as covered by ISO 11608. |
|
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. |
|
Transition Period
FDA recognition of ISO 11608-3 Second edition 2012-10-01 Rec# 6-294 will be superseded by recognition of of ISO 11608-3:2022 Rec# 6-477. FDA will accept declarations of conformity, in support of premarket submissions, to Rec# 6-294 until July 9, 2023. After this transition period, declarations of conformity to Rec# 6-294 will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics Issued May 1999
Guidance on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes. Issued April 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 Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
|
|
*These are provided as examples and others may be applicable. |