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Step 2: Is the Software Function Intended For Administrative Support of a Health Care Facility?

Digital Health Policy Navigator - Step 2

Software functions intended for administrative support of a health care facility are not devices under section 520(o) of the FD&C Act.

Step 2 will help determine if your software function intended for administrative support of a health care facility is a device.

2.A: Is the software function intended for administrative support of a health care facility?

2.B: Is the software function intended for administrative support of laboratories and/or for transferring, storing, converting formats, or displaying clinical laboratory test data and results?

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