| 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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2-228
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| Standard | |
ISO 10993-3 Third edition 2014-10-1
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
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| U.S. Identical Adoption |
Scope/AbstractThis part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:
- genotoxicity;
- carcinogenicity;
- reproductive and developmental toxicity.
This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
NOTE Guidance on selection of tests is provided in ISO 10993-1.
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 4.1.
Clause 5.2.3
Clause 5.3.
Clause 6.2, Sentence, "One animal species is typically sufficient for testing medical devices."
Clause 7.2, Phrase, "or test material"
Annexes A and B |
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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.
This standard is recognized in part because:
Clause 4.1, 5.2.3, 5.3, 7.2 the phrase "or test material", Annex A and B are in conflict with an existing final published guidance, see section IV B and VI. F of FDA biocompatibility guidance (reference #1) listed below.
Clause 6.2, sentence, "One animal species is typically sufficient for testing medical devices" is in conflict with OECD document 116, see section 3.3.1 paragraph 140 of reference #2 below. |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR 58 Good Laboratory Practices for Nonclinical Laboratory Studies |
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Relevant FDA Guidance and/or Supportive Publications*
1. 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.
2. OECD guidance document 116 on the conduct and design of chronic toxicity and carcinogenicity studies, supporting test guidelines 451, 452 and 453, 2nd edition
3. ISO 10993-12 2012 Biological evaluation of medical devices-Part 12: Sample preparation and reference materials.
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. |
