FD&C Act section 520(o), software functions excluded from the device definition, with section 201(h)

Section 201(h) of the Federal Food, Drug, and Cosmetic Act, which defines a device, states that the term does not include software functions excluded under section 520(o).

Section 520(o)(1)(A) excludes a software function 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.

Section 520(o)(1)(B) excludes a software function intended for maintaining or encouraging a healthy lifestyle that is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition. Section 520(o)(1)(C) excludes a software function that serves as electronic patient records, to the extent the records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart.

The electronic-records exclusion applies only if the function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition.

Section 520(o)(1)(D) excludes a software function for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional about that data, general information about those findings, and general background information about the laboratory test or other device.

The data-display exclusion does not cover a function intended to interpret or analyze clinical laboratory test or other device data, results, and findings. Section 520(o)(1)(E), the clinical decision support exclusion, does not cover a function intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system.

The clinical decision support exclusion reaches a function intended for supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition.

It also requires that the function enable the health care professional to independently review the basis for the recommendations so that it is not the intent that the professional rely primarily on any of them to make a clinical diagnosis or treatment decision regarding an individual patient.

For a product with an excluded software function and a function that meets the device definition, the Secretary shall not regulate the excluded software function as a device, but may assess its impact on the device function when assessing the device function's safety and effectiveness.

A software function described in paragraph (1)(C), (D), or (E) is not excluded from the device definition if the Secretary finds that its use would be reasonably likely to have serious adverse health consequences and identifies it in a final order issued after notice in the Federal Register and a comment period of not less than 30 calendar days.

Nothing in section 520(o) limits the Secretary's authority to regulate software as a device if the software meets the criteria under section 513(a)(1)(C). The provision narrows the definition of device in section 201(h) and sets no duty of its own.

A person required to register who proposes to begin introducing a device intended for human use into interstate commerce for commercial distribution must, at least ninety days beforehand, report to the Secretary or an accredited person the class in which the device is classified and the action taken to comply with the requirements of section 514 or 515 that apply to it.

A class III device that is subject to a premarket approval order, or is class III by operation of section 513(f), must have an approved application for premarket approval unless exempt under section 520(g). Section 301(a) prohibits the introduction or delivery for introduction into interstate commerce of a device that is adulterated or misbranded.

A person who violates section 301 shall be imprisoned for not more than one year or fined not more than $1,000, or both, and for a repeat violation or one committed with intent to defraud or mislead, imprisoned for not more than three years or fined not more than $10,000, or both. Proceedings for the enforcement of the Act, or to restrain violations of it, are brought by and in the name of the United States. Section 3060(a) of Public Law 114-255 added subsection (o) to section 520. Public Law 114-255 was enacted on December 13, 2016.