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IDE Responsibilities | FDA
- https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-responsibilities
- Investigator Agreements (§812.43) ... Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects.
Investigational Device Exemption (IDE) | FDA
- https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide
- 21 CFR 812, Investigational Device Exemptions, covers the procedures for the conduct of clinical studies with medical devices including application, responsibilities of …
Device Trial Investigator Agreement Procedures
- https://soph.uab.edu/medicine/ctao/images/Device_Trial_Investigator_Agreement_Procedures_v6-1_Final_07-20-22.pdf
- Device Trial Investigator Agreement Procedure Version 6.1, 5/31/2022 Device Trial Investigator Agreement Procedures Abstract: These procedures describe UAB’s …
Office of the Director | Center for Cancer Research
- https://ccrod.cancer.gov/confluence/download/attachments/77661692/INVESTIGATOR%20AGREEMENT%20for%20devices.docx?version=1&modificationDate=1331664575097&api=v2
- INVESTIGATOR AGREEMENT. ... on human subjects and will allow only those physician co-investigators listed on the last page of this agreement to administer this devices …
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