1
Is the product comprised of software?

Yes

No
2
Is the product designed to effectively treat a disease?

Yes

No
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3
Is the product comprised of software only?

Yes means no ancillary components are involved in the product such as connected hardware device(s), adjunctive pharmacotherapy, or live clinical support


Yes

No
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4
Is the software component of the product the primary mechanism of action in treating the disease?

Yes means the ancillary components, such as connected hardware device(s), adjunctive pharmacotherapy, or live clinical support, are not the primary drivers of efficacy


Yes

No
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5
Could the software component of the product drive meaningful outcomes in the disease as an independent contributor to treatment?

Yes

No
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