Use Of Non-Fda Approved Medical Devices

Expanded Access for Medical Devices | FDA

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

https://law.stackexchange.com/questions/18948/is-it-illegal-for-a-consumer-to-obtain-or-use-a-non-fda-approved-medical-device

The FDA approved the device as requiring a prescription (not OTC). FDA regulations govern the manufacture or distribution of devices and drugs, not the consumption. An …

FDA Facts: The Risks of Promoting Unapproved Uses

https://www.fda.gov/about-fda/innovation-fda/fda-facts-risks-promoting-unapproved-uses

The premarket review and approval provisions of the Federal, Drug, and Cosmetic Act (FD&C Act) are designed to help prevent harm to patients from unsafe and ineffective …

Frequently Asked Questions About Medical Devices

https://www.fda.gov/files/about%20fda/published/Frequently-Asked-Questions-About-Medical-Devices---Information-Sheet.pdf

In accordance with the Federal Food, Drug, and Cosmetic Act, FDA places all medical devices into one of three regulatory classes based on the level of control necessary to …