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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 051 Date of Entry 01/14/2019 
FR Recognition Number 18-2
Standard
ASTM E2535-07 (Reapproved 2018)
Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
Scope/Abstract
This guide describes actions that could be taken by the user to minimize human exposures to unbound, engineered nanoscale particles (UNP) in research, manufacturing, laboratory and other occupational settings where UNP may reasonably be expected to be present. It is intended to provide guidance for controlling such exposures as a cautionary measure where neither relevant exposure standards nor definitive hazard and exposure information exist.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 3.2.5 definition of a nanoparticle
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 3.2.5 is in conflict with existing published final guidance. See "II Discussion A. Points to Consider" in 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.
FDA Technical Contact
 George Ngatha
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  301-796-6444
  george.ngatha@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Nanotechnology
*These are provided as examples and others may be applicable.
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