Step 2: Is the Software Function Intended For Administrative Support of a Health Care Facility?
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?
LIKELY NOT A DEVICE
WHY: Certain software functions intended for administrative support of a health care facility are excluded from the device definition by section 520(o)(1)(A) of the FD&C Act, which states thatthe term device, as defined in section 201(h), "shall not include a software function that is intended for administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management, and laboratory workflow." Considering your answer to the previous question, answering "Yes" to Question 2.A suggests that the software function may not meet the device definition.
If you are unsure, go to Question 2.B to learn about other device criteria and considerations that may apply to your software function.
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
Continue to Question 2.B.
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?
LIKELY NOT A DEVICE
WHY: Certain software functions intended for administrative support of a health care facility are excluded from the device definition by section 520(o)(1)(A) and (D) of the FD&C Act.Specifically, Laboratory Information Systems (LIS) and Laboratory Information Management Systems (LIMS) functions intended for administrative support of laboratories and/or for transferring, storing, converting formats, or displaying clinical laboratory test data and results are not considered to be within the definition of the term device. As a result, these software functions are not subject to device requirements under the FD&C Act. However, some LIS and LIMS include software functions that remain device functions, including software functions that analyze medical device data to provide a notification or flag (for example, that a parameter is out of range), and such functions are devices. Considering your answers to the previous questions, answering "Yes" to Question 2.B suggests that the software function may not meet the device definition.
If you are unsure, go to Step 3 to learn about other device criteria and considerations that may apply to your software function.
LEARN : Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (see Sections IV.A. and IV.D. for examples of software functions intended for transferring, storing, converting formats, or displaying data and results)
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
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