Regulatory Open Forum

Hi RAPS forum,

Does FDA have a definition for "continuous monitoring" for wearable sensors (e.g. glucose, SpO2, etc)? How often do measurements need to be taken for the sensor to be considered "continuous"?

Thank you.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

I have not come across a "generic" definition.  However, the objective of continuous monitoring is important while deciding the
frequency of measurement.  From my experience with seizure detection devices, I would say the frequency should be appropriate
so that you do not miss an "event" or "change" of significant importance.  In some cases such as seizure detection, it can be a
life threatening situation so the data samples are taken every second or few seconds apart.  

It might be for this very application dependency that FDA may have chosen not to define "continuous monitoring" as a generic
definition. I hope this helps.

------------------------------
Hrishikesh Gadagkar
Consultant
RQM+ - Enterprise
Chadds Ford PA
United States
------------------------------

Original Message:
Sent: 06-May-2021 16:01
From: Hiral Dutia
Subject: Continuous sensors

Hi RAPS forum,

Does FDA have a definition for "continuous monitoring" for wearable sensors (e.g. glucose, SpO2, etc)? How often do measurements need to be taken for the sensor to be considered "continuous"?

Thank you.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Hrishikesh - That is helpful. I researched this and could not find anything definitive, so glad to see your comment. Thanks for providing that context.

A little more background - We are evaluating some sensors to use as tools. We are testing out one right now. This sensor was chosen because we were looking for something that provide continuous monitoring. In the demo and in the brochures, the sensor is described as continuously monitoring. However, the sensor's data collection is spotty and definitely not as continuous as we need it to be. When we looked into it, we found that the intended use in the 510k summary is only listed as "spot-checking". We will keep looking, specifically for something that is cleared/approved for continuous monitoring for the particular application we need.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 09-May-2021 17:02
From: Hrishikesh Gadagkar
Subject: Continuous sensors

I have not come across a "generic" definition.  However, the objective of continuous monitoring is important while deciding the
frequency of measurement.  From my experience with seizure detection devices, I would say the frequency should be appropriate
so that you do not miss an "event" or "change" of significant importance.  In some cases such as seizure detection, it can be a
life threatening situation so the data samples are taken every second or few seconds apart.

It might be for this very application dependency that FDA may have chosen not to define "continuous monitoring" as a generic
definition. I hope this helps.

------------------------------
Hrishikesh Gadagkar
Consultant
RQM+ - Enterprise
Chadds Ford PA
United States

Original Message:
Sent: 06-May-2021 16:01
From: Hiral Dutia
Subject: Continuous sensors

Hi RAPS forum,

Does FDA have a definition for "continuous monitoring" for wearable sensors (e.g. glucose, SpO2, etc)? How often do measurements need to be taken for the sensor to be considered "continuous"?

Thank you.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

We have a product that is wearable and measures a body parameter continuously. If it loses sync with the BLE device it stores that data and presents it later when it reconnects. I am not sure the FDA considers "continuous" a claim. They just wanted to see how often we broadcast from the sensor to the smart device and the security of the packets.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 06-May-2021 16:01
From: Hiral Dutia
Subject: Continuous sensors

Hi RAPS forum,

Does FDA have a definition for "continuous monitoring" for wearable sensors (e.g. glucose, SpO2, etc)? How often do measurements need to be taken for the sensor to be considered "continuous"?

Thank you.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------