| ASTM F3320-18 Standard Guide forCoating Characterization of Drug Coated Balloons |
| Recognition Number | Cardiovascular |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 3-158 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Cardiovascular |
| FDA Tech | Eleni Whatley FDA/OMPT/CDRH/ODE/DCD/PIDB/ 301-796-6372 Eleni.Whatley@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| There is no relevant guidance developed at this time. |