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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 2-285
Standard
USP 43-NF38:2020
<87> Biological Reactivity Test, In Vitro - Elution Test
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.
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*
ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.

ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

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.

FDA Technical Contact
 Chandramallika (Molly) Ghosh
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6496
  molly.ghosh@fda.hhs.gov
Standards Development Organization
USP United States Pharmacopeial Convention, Inc. http://www.usp.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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