FDA guidance for MDDS, Medical Images Storage, Medical Image Communications

The gist is this.

The FDA does not intend to enforce compliance with the regulatory controls that apply to the following devices:

1. MDDS subject to 21 CFR 880.6310,
2. Medical image storage devices subject to 21 CFR 892.2010, and
3. Medical image communications devices subject to 21 CFR 892.2020.

This means that for devices that meet the definitions in the regulations listed above, the FDA does not intend to enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting and quality system regulation for manufacturers of these types of devices.

Click to expand...

Guidance is posted here. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm401785.htm

Re: FDA guidance for MDDS, medical images storage, medical image communications.

A Quick Bump!

In case you missed this post and attachment.

WOW.
FDA's position about MDDS and data storage servers is moving towards what's in EU Meddev 2.1/6!
That's a very big change!

However they put MDDS manufacturers in the twilight zone: "FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices".
21.cfr.892 is left unchanged and this document is just a guidance.
Should MDDS manufacturers continue to apply 21.cfr or not?

Another area I'm very curious about -- the guidance calls out certain items that they wont enforce such as registration and the quality system regulations. But they don't say anything about labeling, MDR, and so on.
My assumption is that regulations not mentioned in the guidance would still be enforced. But I would hope that the final guidance would make this an explicit rather than implicit stance.

Makes me wonder how inspections would be handled for the class I device types in question too...

Arianna

I have a question , I suppose a “web/mobile application which collect physiological data from medical device /wellness device, stores the data in its server, displays the data in its dashboard” can be considered as an MDDS, so if this application added with a feature of setting a high and low caution limits /goal settings (by a physician) can be still classified under MDDS?
Note : The application will not be used for real-time patient monitoring.

Have a look at fda web page "identifying a mdds". https://www.fda.gov/MedicalDevices/...pplies/MedicalDeviceDataSystems/ucm251906.htm

It says "MDDS include the following, provided the intended use is consistent with the MDDS regulation: (text stripped) Products specifically labeled (per 21CFR 801) by the manufacturer as an MDDS, provided such products do not provide additional functionality."

Is what you describe a new functionality?
If yes, then your device is probably not consistent with mdds regulation.

More generaly, mdds are hw or sw designed for data storage, transfer, conversion and retrieval. Not interpretation.

Hope it helps!

Limit settings begin to get into a gray area. IMHO it all depends on the intended use of them.

If these are intended to be "memory aids" to provide an indication that the limits have been exceeded I believe they fall within the MDDS guidance or it may not even apply.

If they are intended to drive an action even if not in real time they probably fall outside the MDDS.

If those limits would be used to drive an interpretation they are clearly outside of the MDDS as c.mitch indicated.

The application here collects physiological data from the patient monitors ... store data in a server and have an option to display the data in a physician's view for the respective patients... this also have an option set the normal values for the respective physiological parameters.. if the values goes above this set limits ... the value will be highlighted someway.. i hope this feature can be considered as a simple 'memory aid'.. and the total application can be a MDDS...

Be careful with mdds:
-no real time patient monitoring
-no active patient monitoring
-no alerts on patient condition
(Three ways to say more or less the same thing)
-no diagnosis help or data interpretation

Eg: if the "physician's view" is viewed in real time by the physician (eg like a remote view of the patient monitor), to raise alerts on patient condition, then your device is clearly outside mdds definition.

Hi C.Mitch
Can a DICOM Viewer that claims it is to be 'for Diagnostic Use' classify as an MDDS?
It is my understanding that just showing the original image can be an MDDS, but as soon as you are compressing, changing to Jpeg or manipulating the image in anyway, you are not an MDDS.
I am curious, because a competitor is selling a Medical Image Viewer as a Class I, but they do JPEG, Lossy compression, MIP/MPR/ 3D, Collaboration with drawing tools, etc.

It is my understanding that if you want to market the viewer as Diagnostic, then you needed to do 510(k) for Class II?