SBS - The best value in QMS software

FDA issues first draft guidance document on Mobile Medical Applications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The U.S. Food and Drug Administration (FDA) issued its proposed "Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications".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The draft guidance defines a small subset of mobile medical apps that: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
 

Attachments

Elsmar Forum Sponsor
C

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.)
 
Last edited:
C

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
 
Thread starter Similar threads Forum Replies Date
Ronen E FDA issues draft guidance on form & content of UDI Other US Medical Device Regulations 0
Ronen E FDA issues draft guidance on additive manufacturing Other US Medical Device Regulations 1
M FDA issues draft guidance to replace G95-1 (Application of ISO 10993) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
bio_subbu US FDA issues Draft Guidance on Premarket Approval (PMA) Acceptability Other US Medical Device Regulations 0
Ajit Basrur FDA issues draft guidance on nanotechnology US Food and Drug Administration (FDA) 1
bio_subbu FDA issues draft PMA (Pre-Market Approval) Clinical Study Guidance 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ronen E FDA News FDA issues guidance on bench testing in premarket submissions Other US Medical Device Regulations 0
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
Marc FDA Issues Guidance On Cybersecurity of Medical Devices Other Medical Device and Orthopedic Related Topics 1
bio_subbu FDA issues Guidance on UDI - Frequently Asked Questions, Vol. 1 Other US Medical Device Regulations 1
bio_subbu FDA issues Small Entity Compliance Guidance for UDI Other US Medical Device Regulations 1
Ajit Basrur FDA issues Guidance Document - Benefits-Risks Factors to consider for 510(K) US Food and Drug Administration (FDA) 1
Ajit Basrur FDA issues Final Guidance on Mobile Medical Apps (Applications) US Food and Drug Administration (FDA) 2
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
Ajit Basrur FDA issues Warning Letters for misleading advertising of Lap-Band US Food and Drug Administration (FDA) 3
Ajit Basrur FDA issues 2 Guidance Documents on Nov 10, 2011 US Food and Drug Administration (FDA) 0
bio_subbu FDA Issues Guidance Document on Electrocardiograph (ECG) Electrodes Other US Medical Device Regulations 0
Ajit Basrur FDA Issues Final Regulation on Dental Amalgam 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Ajit Basrur FDA Issues concerns on "e-cigarettes" US Food and Drug Administration (FDA) 4
D FDA Compliance - CMC quality and regulatory issues & cGMP - 21CFR parts 210 and 211 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
J FDA regulation on decorative contact lenses Medical Device and FDA Regulations and Standards News 4
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F FDA classification for a mobile app Medical Information Technology, Medical Software and Health Informatics 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Writing a presubmission to the FDA prior to the De novo submission US Food and Drug Administration (FDA) 4
K FDA - Can we have more than 1 Initial Importer Medical Device and FDA Regulations and Standards News 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
R Importers - For the FDA Registration/ Listing, is the CMO the importer? Medical Device and FDA Regulations and Standards News 6
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 12
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
JoCam FDA Registration for Sub-contract manufacturers Medical Device and FDA Regulations and Standards News 2
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
P Choice of FDA reviewer US Food and Drug Administration (FDA) 6
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
T Definition Human Use (FDA) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
K FDA 510k electrosurgery 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Leveraging FDA 510k Clearance for International Registrations Other Medical Device Regulations World-Wide 2
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
J FDA notification of address change US Food and Drug Administration (FDA) 2
N Usability testing required for FDA IDE (investigational device exemption)? Human Factors and Ergonomics in Engineering 3
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
Watchcat FDA will not tolerate fraud…meaning what, exactly? Other US Medical Device Regulations 6

Similar threads

Top Bottom