Investigational Medical Device

IDE Responsibilities | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-responsibilities

Promotion of Investigational Devices (§812.7) Under §812.7, a sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator cannot:

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 …

Investigational Medical Devices - Hopkins Medicine

https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/devices.html

An investigational medical device is one that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device. 3. How are investigational …

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 …

Investigational Devices - Human Research Protection …

https://irb.ucsf.edu/investigational-devices

Investigational Medical Devices | Research - University …

https://research.virginia.edu/irb-hsr/investigational-medical-devices

Unapproved medical device: is a device that is utilized for a purpose, condition, or use for which the device requires, but does not have, an approved application for premarket …

Investigational Medical Devices | Research - University …

https://research.virginia.edu/irb-hsr/investigational-medical-devices-0

Investigational device means a device, including a transitional device, that is the object of an investigation. A medical device is considered investigational if either condition …

IDE Definitions and Acronyms | FDA

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-definitions-and-acronyms

Investigational device is a device, including a transitional device, that is the object of an investigation. Investigational device exemption (IDE) IDE refers to the regulations …

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 …

What is an investigational device exemption (IDE)?

https://www.news-medical.net/whitepaper/20230119/An-Investigational-Device-Exemption-(IDE)-what-is-it.aspx

An Investigational Device Exemption (IDE) is an application that must be submitted to receive the Food and Drug Administration’s (FDA) approval to use a novel …