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Investigational Device Exemption (IDE) | FDA
- https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide
- An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often...
IDE Regulations | FDA
- https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-regulations
- Expanded Access for Medical Devices Acceptance of Data from Clinical Investigations for Medical Devices IDE Enforcement of Good Clinical Practices (GCP) Regulations Import …
IDE Approval Process | FDA
- https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process
- A significant risk device presents a potential for serious risk to the health, safety, or welfare of a subject. Significant risk devices may include implants, devices …
Clinical Trials and IDE Guidance Documents | FDA
- https://www.fda.gov/medical-devices/investigational-device-exemption-ide/clinical-trials-and-ide-guidance-documents
- Clinical Trials and IDE Guidance Documents FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services …
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