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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 required to support a Premarket ...
IDE Approval Process | FDA
- https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process
- In order to conduct a significant risk device study, a sponsor must: submit a complete IDE application ( §812.20) to FDA for review and obtain FDA approval of the …
FAQs about Investigational Device Exemption | FDA
- https://www.fda.gov/medical-devices/investigational-device-exemption-ide/faqs-about-investigational-device-exemption
- IVD devices that are under study, including IVD devices that are exempt from the IDE regulations, must comply with labeling requirements under 21 CFR 809.10 (c) (2). One of …
IDE Guidance | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-guidance
- 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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