A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining …

Aug 22, 2024 · 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...

An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the …

An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that …

Jun 11, 2025 · If the approved or cleared device is used in the normal course of medical practice, an IDE would likely not be required. An IDE may be required when RWD collection is intended to determine …

What is an Investigational Device Exemption (IDE) and when does it apply? An IDE allows a medical device to be used in human subject research to collect safety and efficacy data in support of a …

Nov 25, 2025 · The FDA website contains several sets of useful and readable guidance documents about investigational devices, including mobile devices. For many studies involving devices, an …

Jul 25, 2024 · Investigational Device Exemption (IDE): An investigational device is an item that is not FDA-approved for marketing in the United States, or an item that is being evaluated for a new and …

The IDE allows researchers to legally test an investigational device, such as a new medical device, diagnostic tool, or equipment, in clinical trials. It is required when the device is not yet approved by …

An investigational device exemption (IDE) allows a medical device that has not received marketing clearance or approval to be shipped for use in a clinical study without complying with other …