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Medical Application Classification in Controlled/Uncontrolled by Mobile App State.

K

kingkobra

#1
We are developing a mobile app as an extension to an existing medical device. This application will use image / video from the medical device .

My Questions :-

1 ) what will be the class of the accessory ? in case of

a) Mobile application is controlling that existing medical device.
b) it is not controlling that existing medical device .

The existing device is classified in class 2 by FDA .
I'll be thankful if anyone can give me any supported doc or link for any such case.

Thanks in advance .
 
Last edited by a moderator:

Marc

Captain Nice
Staff member
Admin
#2
Re: Medical Application Classification in Controlled/Uncontrolled by Mobile App State

A quick "Bump". My Thanks in advance to anyone who can help with this one.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
Re: Medical Application Classification in Controlled/Uncontrolled by Mobile App State

Hi,

From you reference to FDA classification of the existing device I assume that you're interested in the classification of your app as a medical device in the USA.

The FDA definition of an Accessory to a Medical Device is not that clear. In other domains (EC for instance) an object would be defined as such if it was intended by its (legal) manufacturer to ENABLE a Medical Device to achieve its intended purpose (as designated by the Medical Device legal manufacturer). So first you have to consider whether your app is actually an accessory.

If it is actually an accessory to a medical device, it would be classified in the USA in one of 2 ways:
1) Some specific accessories (not many) have their own classification. If yours falls in one of these, the extended device's classification doesn't matter (unless specifically stated otherwise by FDA).
2) All other accessories inherit the classification of the device to which they are accessories.

Your app may also be considered a medical device in its own right, rather than an accessory to one, regardless of it being attached to / fed by / controlling another medical device. This should be determined based on the general Medical Device definition: http://www.fda.gov/medicaldevices/d...nce/overview/classifyyourdevice/ucm051512.htm

BTW, The FDA has guidance on mobile apps: http://www.fda.gov/MedicalDevices/P...dHealth/MobileMedicalApplications/default.htm

Cheers,
Ronen.
 
Last edited:

yodon

Staff member
Super Moderator
#5
Re: Medical Application Classification in Controlled/Uncontrolled by Mobile App State

I completely agree with everything Ronen posted (as usual). One thing you may want to think about is what happens in either case if the app fails? What's the potential for harm (including misdiagnosis, delayed treatment, etc.)? I believe this should also factor into your decisions.
 
K

kingkobra

#6
Re: Medical Application Classification in Controlled/Uncontrolled by Mobile App State

Hi Ronen and Yodon ,

First of all , Thanx for your valuable inputs .

Now According to the draft guidance released by FDA on 25 Sept 2013 [document is attached with this post ] at 13/14 page number ,

FDA has stated that they have decided to oversight some kind of application,
one of them is ...

Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.

Here further they are giving these details ,

Mobile medical apps of this type are considered an accessory to the connected device and are required to comply with the controls applicable to that connected device. The FDA considers such mobile medical apps to extend the intended use and functionality of the connected medical device. As a result, the mobile medical app would be required to comply with the regulations applicable to the connected medical device in order to address any associated risks.

So According to this can I say my mobile medical app as an accessory to the already existed medical device ?
 

Attachments

J

Julie O

#7
Re: Medical Application Classification in Controlled/Uncontrolled by Mobile App State

If the "image / video from the medical device" is patient-specific data, then yes, that's how I would interpret this guidance.
 
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