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Questions and Answers
What agreement must an investigator conducting a study of a medical device under an IDE complete and sign?
What agreement must an investigator conducting a study of a medical device under an IDE complete and sign?
An investigator's agreement
When is a 510(k) Premarket Notification submitted?
When is a 510(k) Premarket Notification submitted?
When the new device to be marketed is substantially similar (equivalent) to one already on the market
Who must report Evaluation of Unanticipated Adverse Device Effects (UADEs) to the FDA?
Who must report Evaluation of Unanticipated Adverse Device Effects (UADEs) to the FDA?
Sponsor
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Study Notes
Investigator Responsibilities
- An investigator must complete and sign an investigator's agreement when conducting a study under an Investigational Device Exemption (IDE).
510(k) Premarket Notification
- A 510(k) is required when a new medical device is substantially similar to an existing device already on the market, indicating equivalence in terms of safety and effectiveness.
Reporting Requirements
- Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the sponsor of the study or device.
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