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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 047 Date of Entry 08/21/2017 
FR Recognition Number 2-155
Standard
ASTM F2147-01 (Reapproved 2016)
Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
Scope/Abstract
1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.

1.2 This practice is intended as an alternative to the Guinea Pig Maximization Test (GPMT), given the limitations on dosage form and tendency for false positives associated with the latter test. See Rationale and References.
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*
Use of International Standard ISO 10993-1, Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process. Guidance for Industry and Food and Drug Administration Staff. Issued on June 16, 2016
FDA Technical Contact
 Chandramallika (Molly) Ghosh
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6496
  molly.ghosh@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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