FDA Medical Device Data Systems Final Rule

[Matt Estrella]

In regards to the FDA’s Final Rule in reclassifying MDDSs from Class III to Class I, does anyone have a good understanding as to how this would apply to the interface engine and the functionality it provides?  We are trying to determine if how we use our interface engine and the associated software qualifies our facility (a Health Delivery Organization) to register as a manufacturer with the FDA.

After reviewing the regulation, I seem (and want to) believe that translations created would not qualify as nothing is changed intrinsicly to the software or hardware between the vendor systems or with the interface engine itself.

Any thoughts?

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