Good day Elizabeth,
Indeed the terms Research Use Only (RUO) and Investigation Use Only (IUO) can be used outside of IVD products and often are. If the device is a wrist-worn wearable, it could be labelled as RUO to allow users to "feel" the device through size, weight, adjustable, etc. It could even have screen options which does not give the user any type of information, something akin to a formative usability study or market research, certainly should not provide any physiological parameters. The wrist-worn wearable could also be part of an investigational study labelled as IUO which could then be used as intended allowing users to gather, see, and use information presented by the wearable device - of course all within the confines of the clinical study.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 11-Sep-2023 13:15
From: Elizabeth Pendley
Subject: CAn RUO and IUO designations apply outside of IVDs?
Can RUO and IUO designations apply outside of IVDs? For example, for a wrist-worn wearable that has technology similar to PPG, but is still in development phase how could a manufacturer partner with a customer to continue development prior to formal design control?