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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 3-153
Standard
ASTM  F2743-11
Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
Scope/Abstract
This guide describes recommended in vitro test proceduresfor coating inspection and acute particulate characterizationof coated drug-eluting vascular (balloon-expandable andself-expanding) stent systems.
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.
Relevant FDA Guidance and/or Supportive Publications*
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 Contacts
 Eleni Whatley
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  301-796-6372
  Eleni.Whatley@fda.hhs.gov
 Jason Weaver
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2504
  Jason.Weaver@fda.hhs.gov
 Samuel Raben
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-6629
  Samuel.Raben@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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