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126. FDA Regulations: Investigational Device Exemption Categories (§812.2(c))

For research involving the assessment of the safety or effectiveness of a device in humans, the following may be exempt from the requirement for IDE:

1.      A device other than a transitional device

·        that was in commercial distribution immediately before May 28, 1976 and

·        is used or investigated according to the indications in labeling in effect at that time.

2.      A device other than a transitional device

·        that was introduced into commercial distribution on or after May 28, 1976, and FDA determined it is substantially equivalent (under subpart E of part 807) to a device in commercial distribution immediately before May 28, 1976; and

·        is used or investigated according to the indications in the labeling reviewed by FDA in determining substantial equivalence.

3.      A diagnostic device if the sponsor complies with the requirements for labeling in vitro diagnostic products as "for research" or "for investigational" use only (§809.10(c)); and if the testing

·        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.

4.      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 safety or effectiveness and does not put subjects at risk.

5.      A custom device (see definitions) if that device is not being used to determine safety or effectiveness for commercial distribution.

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