Some studies may be exempt from the IDE regulations. The exemption criteria is explained in 21 CFR 812.2(c), and briefly summarized here:
- A legally marketed device when used in accordance with its labeling;
- A diagnostic device, if it is
- noninvasive;
- does not require an invasive sampling procedure that presents significant risk;
- does not by design or intention introduce energy into a subject;
- and is not used as a diagnostic procedure without confirmation of the diagnosis by another medically established diagnostic product or procedure.
- 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 safety or effectiveness and does not put subjects at risk;
- A device intended solely for veterinary use;
- A device shipped solely for research with laboratory animals; A custom device as defined in 812.3(b).
The Office for Research Protections Quality Assurance Program can help investigators determine if their device study is IDE exempt. Contact them at orp-qm@psu.edu.
Research Topic