Medical Device Software Version Upgrade Regulation Impact

[kingkobra]

We are making an mobile application which is an accessory to the already existed medical device .

So in case of FDA , Can anyone please tell us what will be regulatory impact in case of

1) application version upgrade

2) mobile platform OS Upgrade

 

[sreenu927]

Re: Version Upgrade Regulation Impact

Hi Kingkobra,

Use the following guidance to evaluate the change and your decision.

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/ucm080243.pdf

1. Assess the change by performing impact assessment or risk analysis.
2. Review your design input and design output docs.
3. Perform Verification and/or validation (and document properly).
4. Based on the risk and V&V docs, decide it whether it just requires documentation or a new 510(k) submission.

Regards,
Sreenu

 

[kingkobra]

Re: Version Upgrade Regulation Impact

Hi Kingkobra,

Use the following guidance to evaluate the change and your decision.

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/ucm080243.pdf

1. Assess the change by performing impact assessment or risk analysis.
2. Review your design input and design output docs.
3. Perform Verification and/or validation (and document properly).
4. Based on the risk and V&V docs, decide it whether it just requires documentation or a new 510(k) submission.

Regards,
Sreenu

Thanks sreenu .

I think in the document It is mentioned about the version control of my application . Agreed . but can you please tell me what to do if there is any change in OS version . [like In case of windows upgrade and android upgrade].

 

[sreenu927]

For OS upgrade, it requires new 510(k) submission. But yet again, it depends on the risk impact
- whether any new features are added into the OS impacting the performance, speed of programming, printer /network capabilities, etc...
accordingly, you need to take decision.

On the other hand, you can also refer to this EU NB MED 2.5.2/Rec.2 Guidance:
http://www.meddev.info/_documents/R2_5_2-2_rev7.pdf

Section 5.2 Changes to EC-approved medical devices design/type (including software)
(MDD Annexes II, 4.4 and III; IVDD Annexes VI-4.2 and V, respectively):
a) Reportable change:
- Changes to the medical device
included computer software (e.g. new functionalities, new algorithms for
computing) which will change the specifications and / or performances of the
device (e.g. changes of those materials which have to be biocompatible or
changes of main components like power source, Central Processing Unit
(CPU), defibrillator-capacitors etc.)
- new operating systems

are substantial changes.

Hope this helps to understand and analyze your case further!

Regards,
Sreenu