Expanded Patient Access to Investigational New Devices

Author:

Van Norman Gail A.

Publisher

Elsevier BV

Subject

Cardiology and Cardiovascular Medicine

Reference39 articles.

1. Drugs, devices, and the FDA: part 2. An overview of approval processes: FDA approval of medical devices;Van Norman;J Am Coll Cardiol Basic Trans Science,2016

2. U.S. Food and Drug Administration. Device Advice: Investigational Device Exemption (IDE). Available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm. Accessed May 31, 2018.

3. U.S. Food and Drug Administration. Guidance on IDE Policies and Procedures. Available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080202.htm. Accessed June 23, 2018.

4. Drugs, devices and the FDA: part 1: an overview of approval processes for drugs;Van Norman;J Am Coll Cardiol Basic Trans Science,2016

5. U.S. Food and Drug Administration. Expanded Access for Medical Devices. January 1, 2018. Available at: https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/investigationaldeviceexemptionide/ucm051345.htm. Accessed June 2, 2018.

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