Software as Medical Device (SaMD) definition and its applicability

akp060

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Hello Members,
If we have a Software that meets IMDRF Medical Device definition, and we say that we are using a hardware medical device (which has got regulatory approval/clearance) as an accessory to SaMD, does it mean that it now a Medical Device System and not an SaMD? I am clear that this is not the case, but checking if I could be wrong or other regulatory resources I have not considered. I know SaMD cannot be part of a medical device integrated or accessory, but if a Medical Device Software (62304 terminology) is a medical device in its own and used hardware medical device as accessory, do we still see the software as SaMD?
 
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akp060

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Take a look at the Key Definitions guidance for major clarity.
Standalone Medical Device Software Harmonization (SaMD)[/QUOTE]

Thank You. I have already looked there but i did not get clarity on my query about accessory to SaMD. However, may I ask about the instance you have mentioned; if you are calling the hardware that provides inputs to SaMD, as the SaMD's accessory
 

primavesvera

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Take a look at the Key Definitions guidance for major clarity.
Standalone Medical Device Software Harmonization (SaMD)

Thank You. I have already looked there but i did not get clarity on my query about accessory to SaMD. However, may I ask about the instance you have mentioned; if you are calling the hardware that provides inputs to SaMD, as the SaMD's accessory[/QUOTE]

No, we treat them as a two separate devices, two different intended use.
 

akp060

Involved In Discussions
Thank You. I have already looked there but i did not get clarity on my query about accessory to SaMD. However, may I ask about the instance you have mentioned; if you are calling the hardware that provides inputs to SaMD, as the SaMD's accessory

No, we treat them as a two separate devices, two different intended use.[/QUOTE]


Thank You, meanwhile, I checked the Accessory guidance from the FDA, and also based on your post, I now have the answer. Thank you so much!

FDA requires that for calling any device as an accessory it should be labeled for use with the Subject Device, in my case the SaMD.
 
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