| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
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057
|
Date of Entry 12/20/2021
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|
FR Recognition Number
|
2-292
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| Standard | |
USP-NF M98833_01_01
<87> Biological Reactivity Test, In Vitro - Direct Contact Test |
|
| 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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
|
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. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
|
|
| *These are provided as examples and others may be applicable. |
