Understanding the Investigational Device Exemption (IDE) Process
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Understanding the Investigational Device Exemption (IDE) Process
In this episode of the Global Medical Device Podcast Jon Speer and guest David Pudwill discuss FDA’s Investigational Device Exemption (IDE) process, which allows an investigational device to be used in a clinical study to collect safety and effectiveness data.
Mar 31, 2021
Investigational Device Exemption Process
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Lungpacer Medical Announces Investigational Device Exemption (IDE) for STARI, Phase 2 Feasibility Clinical Trial
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4.9K views · 49 reactions | News: Cook Medical has been approved to initiate an Investigational Device Exemption (IDE) study. This clinical study is the first U.S. head-to-head evaluation of its kind. Read more: https://www.cookmedical.com/newsroom/fda-approves-first-of-its-kind-ide-clinical-study-of-advance-evero-18-everolimus-coated-pta-balloon-catheter/ #cookmedical #clinicalstudy #medicaldevice #innovation | Cook Medical | Facebook
0:05
4.9K views · 49 reactions | News: Cook Medical has been approved to initiate an Investigational Device Exemption (IDE) study. This clinical study is the first U.S. head-to-head evaluation of its kind. Read more: https://www.cookmedical.com/newsroom/fda-approves-first-of-its-kind-ide-clinical-study-of-advance-evero-18-everolimus-coated-pta-balloon-catheter/ #cookmedical #clinicalstudy #medicaldevice #innovation | Cook Medical | Facebook
FacebookCook Medical
1.2K views2 weeks ago
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