Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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057
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Date of Entry 12/20/2021
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FR Recognition Number
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2-292
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Standard | |
USP-NF M98833_01_01 <87> Biological Reactivity Test, In Vitro - Direct Contact Test |
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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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Public Law, CFR Citation(s) and Procode(s)*
21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
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Relevant FDA Guidance and/or Supportive Publications*
DOI: https://doi.org/10.31003/USPNF_M98833_01_01.
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
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 June 2016. Updated September 2020.
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 Contact
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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. |