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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 2-295
Standard(Included in ASCA)
USP-NF  M98900_01_01
<151> Pyrogen Test (USP Rabbit Test)
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Last sentence of first paragraph "A validated, equivalent in vitro pyrogen or bacterial endotoxin test may be used in place of the in vivo rabbit pyrogen test, where appropriate."
Section "Radioactive Pharmaceuticals."
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:
The last sentence of the first paragraph is in conflict with an existing published final guidance, see section VI. D of the listed guidance (reference #1) below.
Section "Radioactive Pharmaceuticals" is not relevant to medical devices under FD&C act.
ASCA Notes
Used in conjunction with ISO 10993-11: 2017 (recognition number 2-255).
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*
1. 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.

2. Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, Issued June 2012.

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

4. DOI: https://doi.org/10.31003/USPNF_M98900_01_01.

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
 Chandramallika (Molly) Ghosh
Standards Development Organization
USP-NF United States Pharmacopeia (USP) and the National Formulary (NF) http://www.uspnf.com/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.