| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
|
050
|
Date of Entry 09/17/2018
|
|
FR Recognition Number
|
2-256
|
| Standard | (Included in ASCA) |
ASTM F720-17
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test |
|
Scope/Abstract| 1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity. |
|
| Extent of Recognition
|
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. |
|
ASCA Notes
| Used in conjunction with ISO 10993-10: 2010 (recognition number 2-174). |
|
Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
|
Relevant FDA Guidance and/or Supportive Publications*
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
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.
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 Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
