Investigational Device Exemptions
What approval do I need before I can test my device on humans?
In many cases, a medical device will need to be tested on human subjects to generate the data needed to demonstrate safety and efficacy before being approved or cleared for market introduction.
All human testing of any non-marketed medical device, as well as testing of “new indications” for a marketed device, must follow Good Clinical Practice (GCP) guidelines. GCP includes the potential requirement of an Investigational Device Exemption (IDE), approval of the study from an Institutional Review Board (IRB), and obtaining “informed consent” from the study participants.
All clinical studies must be monitored by qualified, trained individuals to ensure that the study is being conducted in accordance with the IDE and applicable FDA regulations.
NOTE: Devices that are considered to have “significant risk” (SR) must obtain an IDE from the FDA.
FDA identifies a Significant (SR) Risk Device as an investigational device that:
- Is intended as an implant and presents potential for serious risk to the health, safety or welfare of subjects
- Is intended to be used to support or sustain human life and presents a potential for serious risk to the health, safety or welfare of subjects
- Is for a use of substantial importance in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety or welfare of subjects
- Otherwise presents a potential for serious risk to the health, safety or welfare of subjects.
Devices that are considered to have “non-significant risk” (NSR) are deemed to have an approved IDE if they comply with the abbreviated IDE requirements set forth in 21CFR 812.2(b). NSR devices will still need IRB approval before being tested on humans and must be labeled properly, including the statement:
“CAUTION – Investigational Device Limited by U.S. law to investigational use only”
For more information on the regulatory requirements associated with clinical testing of medical devices, visit this FDA site.