FDA issues first draft guidance document on Mobile Medical Applications

bio_subbu

Super Moderator
#1
Dear All

The U.S. Food and Drug Administration (FDA) issued its proposed "Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications". The agency is seeking comments and suggestions regarding this aforesaid draft document, which described its proposed oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications ("apps") that are designed for use on smart phones and other mobile computing devices.

The draft guidance defines a small subset of mobile medical apps that:

- is used as an accessory to a regulated medical device; or,
- transforms a commercial off-the-shelf computing platform into a regulated medical device.

For more details please refer here.

Regards
S.Subramaniam
 

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cwrx777

#6
My application is a mobile application that receive Blood pressure measurement from a Bluetooth Blood pressure monitor and transmit the measurement to the server.

According to the guideline, this application is considered as mobile medical application because it is " an extension of one or more medical device(s) by connecting (may not be physically connected) to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data."

I find it difficult to create the device hazard analysis documentation. do you guys have any suggestions?
 

sagai

Quite Involved in Discussions
#7
Your post stipulates me that there is a potential that you find it difficult because there was no related activities carried out though ...

Have you done any hazard related activities on the way you have developed your application?
Hazard analysis is not a made-up document, it reflects the systematic activities carried out as part of product risk management ...

Cheers!
 
C

cwrx777

#8
Hi sagai,

Thanks for replying.

No, I didn't do hazard analysis when designing the application. i need to do this now because we need to submit this docs to FDA.

I cant really thing of any hazards that will cause harm to the patient when he/she is using the application. The possible hazards i can think of are like failure in receiving the measurement becoz of human error e.g the blood pressure monitor is too far from the mobile phone, or bluetooth is not enabled on the phone, or the remote server is down, things like that.


The application is similar to "myfitnesscompanion" or "blood pressure log" in google play.
 

sagai

Quite Involved in Discussions
#9
Doing this duty retrospectively makes the whole thing almost impossible to do properly due to the fact that now, it possibly would be the tremendous job to do any redesign in order to reflect to any safety consideration.
The other thing is that this particular activity cannot effectively be carried out by engineers only. I know, it may sounds strange, I know engineers are the superheros of our age, but clearly there is a need to involve medical expert (I mean trained and practicing physician ) to consider the hazards may arise as part of the use of your applications. The actual work however should involve engineers to see the actual implementation considerations as well to see how to put control measures to eliminate or to limit somehow the identified causes.

Actually I do not think that there is only a few hazards to be consider.
This hazard stuff is in an infinite universe without having a 100% confidance.
Your software can go wrong infinite ways and the medical extent on patient harm of such ways can not be controlled if you do not have proper product risk management activities in place throughout the whole development cycle, including post market surveillance.

In general, there is a comprehensive document I would advise, it costs money, but it is inevitably a great help for this purpose.
There is a preview of it, please find here.

Are you sure if your software is a medical device on its own and you are the manufacturer and you comply with 21CFR820 as well ?

sorry for these questions, I am completely ignorant of the actual situation you are in and these may or may not effect the proper answer.

Cheers!


ps.: one more thing.
with experience, it is possible to compile a fake document itself that potentially will pass the regulator regardless there was no conscious activity as regard.
BUT ... I think we are responsible for the others and we must do our best to safeguard our fellow passengers on this planet without compromising on economical consideration. (I do not refer to the recent madness about this in EN ISO14971:2012, but to the general concept.)
 
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cwrx777

#10
Hi sagai,

Thanks again for your reply.

According to "Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications" section V.A:

A. Mobile medical apps for which FDA will apply regulatory oversight

"Mobile apps that are an extension of one or more medical device(s) by connecting(17) to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data."

17 To meet this criterion, the mobile medical apps need not be physically connected to the regulated medical device.

AS i mentioned previously, my application receives BP measurement via Bluetooth, stores it in application sqlite database and transmit it to a backend server for review via web interface.

So yes, according to FDA, my android application is a medical "device".

We never thought that this application will eventually be marketed in the US, so we didn't do any 'hazard analysis'.


I just couldn't think of any hazard that will cause harm to the user when it's used according to the intended use.

There're similar app that apply for 510(k)
K120325
 
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