Medical Device

• The FDA recommends a two-step process to determine whether a device needs to be regulated as a medical device. Step 1 is to use Section 201(h) of the Food, Drug & Cosmetic Act (FD&C) to see if the device meets the definition of a medical device. If the determination is yes, then step 2 is to see if an appropriate classification exists.
• According to our reading of the description provided of the iDetect, it would likely be considered a medical device according to Section 201(h) because it is "...intended for use in the diagnosis of disease or other conditions..."
• However, in September 2019, the FDA published a guidance document that was intended to provide clarification around when mobile medical software is considered to be a medical device. "Some software functions may meet the definition of a medical device, but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act)." It seems possible that iDetect may fall into this category, but without all the details it is impossible to know for sure.

Institutional Review Board (IRB)

• Based on this document from the National Institutes of Health (NIH), any research that involves human subjects appears to require an IRB.
• According to the FDA, "regulations permit an institution without an IRB to arrange for an "outside" IRB to be responsible for initial and continuing review of studies conducted at the non-IRB institution. Such arrangements should be documented in writing. Individuals conducting research in a non-institutional setting often use established IRBs (independent or institutional) rather than form their own IRBs." Solutions IRB appears to be one such company.
•  Part 46 of the Electronic Code of Federal Regulations discusses the "Protection of Human Subjects." Section 46.104 discusses exemptions to the policy and this could be reviewed further to determine if this research would be exempt.

Medical Device Consulting Firms

• In the course of our research, we discovered there are consulting firms that work with companies to help them determine whether their software is considered a medical device and , if so, what the next steps should be. One example is Emergo.

Summary of Findings

• In our initial research, we were able to determine that it is likely iDetect would be considered a medical device, but would possibly not be subject to the FD&C act due to the low risk of harm.
• Of note, the guidelines surrounding medical devices is complex, and our brief review should not be considered legal advice as we are not experts.
• Initial research also touched on IRBs, but we were not able to definitively determine whether iDevice would be subject to an IRB review. However, if it is, using an established IRB would be an option rather than establishing one.
• As we would not be able to make any definitive determinations even with further review of the material, our proposed next steps focus on finding the resources that could provide the answers needed.