Hello Anon,
The basic requirement is medical device can only be used with, on, for, or in humans which has been been properly registered, cleared, or approved according to its intended. There are ways a "non-approved" product could be used such as in marketing trials or usability studies where the device is not fully functional or operational according to its intended use. If you want individuals to be able to "play around with" or see some of the features, that may be fine, just lots of warnings that the information is not correct and for simulation only. I have done in the past where we used devices for trials or initial testing, but this was only internal to the company on employees who volunteered. If the product is going to be used for gathering data, then a clinical trial needs to be in place. If the product is going to be used to let individual see the features and try out the device, really it needs to be non-functional or not provide the treatment/results according to the intended use. There are some different things which can be implemented, though really depends on how the device is usable.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 01-Dec-2023 12:38
From: Anne LeBlanc
Subject: Real-world demonstration of regulated feature/device showing biometric measurements without FDA clearance
Hello Anon
The scenarios you mention all have different requirements... It will be important to define clearly what you're actually doing.
For trade shows, see this letter: https://www.fda.gov/media/113972/download
For trying it out on guests, are you doing human testing, and/or gathering personal data, or just playing around in the lab?
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Anne LeBlanc
United States
Original Message:
Sent: 30-Nov-2023 20:59
From: Anonymous Member
Subject: Real-world demonstration of regulated feature/device showing biometric measurements without FDA clearance
This message was posted by a user wishing to remain anonymous
Greetings forum
I'm working with a startup that is using wearable sensor technology to generate biometric data for remote clinical monitoring of blood pressure (BP). Currently in early design control, marketing and product are eager to showcase the device in it's current state to external parties (e.g., board members, industry trade show attendees, potential investors) by actually putting the device on said person to let them "see" how well it works and allowing them to both generate and then view their own blood pressure measurement. The intent is to fundraise in support of further development and productization for this medical device.
From a regulatory perspective I think showcasing the device this way and allowing a user to generate/view their BP measurement is technically breaking the law, isn't it? If the usage is to (albeit loosely) demonstrate the thing "works" (effectiveness) in order to generate revenue/support for the development effort (marketing for profit?) of a product we already know is a medical device, then doing so would be in violation of some laws, correct? Further, to mitigate risk I was thinking that as long as we complied with 21 CFR 812, and a) labeled the device accordingly ("investigational use" language), b) documented a risk assessment w/NSR rationale, c) and executed said demonstrations under IRB-approved protocol (participant signatures on ICs, etc.), any risk of using an unauthorized medical device would be mitigated. But I'm not sure if I'm overthinking this? I keep getting told there is no harm in these types of demonstrations without regulatory controls in place in this "onesie-twosie" capacity for fundraising purposes, and (my favorite) that "medical device startups/everyone else do(es) it all the time so why can't we?".....
Does anyone have any insight and/or thoughts on how to appropriately manage a scenario like this?