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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 2-287
Standard(Included in ASCA pilot)
USP 43-NF38:2020
<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 June 2016. Updated September 2020.

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.
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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