| Part B: Supplementary Information Sheet (SIS) |
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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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2-294
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| Standard | |
USP-NF M98834_01_01
<88> Biological Reactivity Tests, In Vivo |
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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." |
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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:
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. |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR Part 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_M98834_01_01.
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.
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.
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. |
