A client presented us with a simple question – Do we need to submit an Investigational Device Exemption (IDE) application before conducting a clinical study on our device in the U.S.? – which turned into a good lesson about persistence in regulatory research.
The client’s product was an electronic device for monitoring one of the body’s many physiological signals. (The specific signal is not relevant to our story.) It displays those signals, but does not interpret them or provide a diagnosis. Most devices require an FDA-approved IDE application before conducting a clinical study in the U.S. “Non-significant risk” devices are exempt from FDA approval requirements, but still must comply with other IDE requirements (e.g., IRB approval, informed consent requirements, monitoring the conduct of the study). “Exempt” devices are exempt from all IDE requirements. The IDE regulations state (at 21 CFR 812.2):
“(c) Exempted investigations. This part, with the exception of 812.119 [Disqualification of a clinical investigator], does not apply to investigations of the following categories of devices:
(3) A diagnostic device, if the sponsor complies with applicable requirements in 809.10(c) [concerning labeling of in vitro diagnostics] and if the testing:
(i) Is noninvasive,
(ii) Does not require an invasive sampling procedure that presents significant risk,
(iii) Does not by design or intention introduce energy into a subject, and
(iv) Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.”
Our client’s diagnostic device did not require an invasive sampling procedure, so the proposed study met (3)(i) and (3)(ii). The proposed study included confirmation of the output of the investigational device by an established product, so the proposed study also met (3)(iv). But what about (3)(iii), concerning introduction of energy? The device was electronic, so it did indeed introduce some electrical energy: leakage current to the body is inevitable in any body-contacting electronic device. But how does FDA interpret “by design or intention”? The regulation does not define the phrase and FDA has not published guidance on these exemptions from IDE regulations. On a more “gut” level, the regulation appears to create an exemption for in vitro diagnostics and not so clearly for our client’s device.
What would you do next? Give up? Call FDA? Call a lawyer? Find out how we met our client’s needs with this case in our next post, Regulatory research on IDE exemptions: A case study in persistence part 2.
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