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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 3-158
Standard
ASTM F3320-18
Standard Guide forCoating Characterization of Drug Coated Balloons
Scope/Abstract
1.1 This guide describes recommended acute in-vitro characterization methods for drug coated balloon (DCB) coatings. These methods include: coating integrity, coating thickness, drug coating uniformity, and released particulates. Specifically, this guide details:

1.1.1 Characterization of integrity by inspection of the coated balloon surface.

1.1.2 Measurement of coating thickness.

1.1.3 Quantitation of drug coating uniformity (uniformity of drug distribution over the balloon surface) longitudinally and circumferentially.

1.1.4 Quantitation of the number of particulates released, in various ranges, during simulated use testing (insertion, tracking, deployment, retraction, and withdrawal) along with chemical and crystallinity characterization of particulates.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Unclassified Drug-Coated Peripheral Transluminal Angioplasty Catheter Class 3 PRC
Unclassified Drug-Eluting Peripheral Transluminal Angioplasty Catheter Class 3 ONU
FDA Technical Contact
 Eleni Whatley
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  301-796-6372
  Eleni.Whatley@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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