Class IIB Medical Device Accessories - OTS Tablets

#1
Hello,

1.We are a class IIB medical device company and we use some accessories like tablet. We buy them off the shelf and upload our data acquisition software (not a fancy one, just exports data into CSV format) and the tablet doesnot affect the intended use of the device. Is this considered as an accessory? FDA accessory guidance states that "FDA would generally not consider a mobile phone that is used as a general platform for applications that include mobile medical applications that are medical devices or an off-the-shelf computer monitor used to display medical data as accessories unless they are specifically intended for use with such medical devices. " (page 6)

2. Are phantoms considered as accessories ?

3. In general, what needs to be done if we plan on adding accessories.
 
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