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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 14-427
Standard
ISO  13408-1 Second edition 2008-06-15
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
Scope/Abstract
ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.
ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.
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FDA recognition of ISO 13408-1 Second edition 2008-06 [Including: Amendment 1 (2013)] [Rec# 14-427] will be superseded by recognition of ISO 13408-1 Third edition 2023-08 [Rec# 14-592]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-427] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 14-427] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, issued September 2004.

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 Contacts
 Poulomi Nandy
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-7048
  Poulomi.Nandy@fda.hhs.gov
 Anita Khatiwara
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  240-402-1710
  Anita.Khatiwara@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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