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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 2-286
Standard
USP 43-NF38:2020
<88> Biological Reactivity Tests, In Vivo
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Page 171, Sentences, "Remove particulate matter, such as lint and free particles, by treating each subdivided Sample or Negative Control as follows. Place the Sample into a clean, glass-stoppered, 100-mL graduated cylinder of Type I glass, and add about 70 mL of Water for Injection. Agitate for about 30 s, and drain off the water. Repeat this step."

Pages 174-175, Section "Safety Tests - Biologicals."
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:
Page 171, Sentences, "Remove particulate matter, such as lint and free particles, by treating each subdivided Sample or Negative Control as follows. Place the Sample into a clean, glass-stoppered, 100-mL graduated cylinder of Type I glass, and add about 70 mL of Water for Injection. Agitate for about 30 s, and drain off the water. Repeat this step." is in conflict with an existing published final guidance. See section V.C and section V. E. bullet 5 of the guidance listed below.
Pages 174-175, Section "Safety Tests - Biologicals" is in conflict with another recognized standard, see ISO 10993-11.
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*
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.

ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
FDA Technical Contact
 Jennifer Goode
  FDA/OC/CDRH/OPEQ/CSPS/
  301-796-6374
  jennifer.goode@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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