Informed Consent for Formative Usability Evaluations

[BuckeyeBurro]

Hello,

I am part of a team working towards a formative usability study for our upcoming medical device. The device is class II, 510(k)-exempt (code PJT) (confirmed with FDA). We intend to perform a 4-week, 10-person study, where each person is given a prototype of our device and asked to integrate it into their daily life. We intend to use the data from this study to (1) inform our design before our production-ready version and (2) give us early indications of the benefit provided by the device.

As we have been preparing to start this trial (a couple of months out), I want to make sure we are covered with respect to Informed Consent regulations. I am not confident whether Informed Consent is required for our device, and I want to get additional perspectives.

First, what do the regs say?

21 CFR 50.1: This part applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Additional specific obligations and commitments of, and standards of conduct for, persons who sponsor or monitor clinical investigations involving particular test articles may also be found in other parts (e.g., parts 312 and 812). Compliance with these parts is intended to protect the rights and safety of subjects involved in investigations filed with the Food and Drug Administration pursuant to sections 403, 406, 409, 412, 413, 502, 503, 505, 510, 513-516, 518-520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act.

How do the regulations define "clinical investigations?"

21 CFR 50.3(c): any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding nonclinical laboratory studies.

The definition for clinical investigations is specific to say "subject to requirements for prior submission" and "results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit."

Given our device is 510(k)-exempt, is this regulation and the requirements for Informed Consent applicable?

 

[Ed Panek]

I’ve completed several human factors tests my self. My experience of informed consent is about risk. In our case we asked testers to download an app, enter some credentials and perform the essential performance of the app. That’s it.

We had a script we read but there was no consent required for our report.

Informed consent would be needed if current healthcare SOC were being replaced or augmented with our proposed device.

However our device measures temperature. Temperature measurement of the general public isn’t necessarily impacting health care decisions. If we were testing our device on hospital patients at risk of fever informed consent would probably be needed.