| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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038
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Date of Entry 01/27/2015
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|
FR Recognition Number
|
18-3
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| Standard | |
ISO TS 14101 First edition 2012-11-01
Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
3.7 nano-object
3.8 nanoparticles
3.9 nanoscales |
|
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:
Section 3.7, 3.8 and 3.9 are in conflict with published final guidance. See "II Discussion A. Points to Consider" in the guidance listed below. |
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology", Issued June 2014
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. |
