| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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044
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Date of Entry 07/26/2016
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FR Recognition Number
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2-222
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| Standard | |
ISO 10993-2 Second edition 2006-07-15
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
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Identical AdoptionANSI AAMI ISO 10993-2:2006/(R)2014
Biological Evaluation of medical devices - Part 2: Animal welfare requirements |
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Scope/AbstractThis part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. It specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices.
It also makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.
It applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.
It does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized. |
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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 10993-2 Second edition 2006-07-15 [Rec# 2-222] will be superseded by recognition of ISO 10993-2 Third edition 2022-11 [Rec# 2-300]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-222] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 2-222] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff. General Considerations for Animal Studies for Cardiovascular Devices. 29 July 2010.
Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued September 2023.
FDA Draft Guidance: General Considerations for Animal Studies for Medical Devices, which, when final will represent the Agency's thinking on this topic.
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. |
