Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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040
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Date of Entry 08/14/2015
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FR Recognition Number
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18-4
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Standard | |
ISO TS 80004-6 First edition 2013-11-01 Nanotechnologies - Vocabulary - Part 6: Nano-object characterization |
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Scope/AbstractThis Technical Specification lists terms and definitions relevant to the characterization of nano-objects.
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Extent of Recognition
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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. |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Issued June 2014 |
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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. |