On October 22, Rep. Marsha Blackburn (R-TN) introduced a bill serving to “provide for regulating medical software, and for other purposes” in the House of Representatives. The bill, entitled the Sensible Oversight for Technology which Advances Regulatory Efficiency (“SOFTWARE”) Act (“the bill”), was co-sponsored by a bi-partisan group of lawmakers.
The bill creates a regulatory scheme based on three newly defined categories of software—“medical software,” “clinical software,” and “health software.” Although the bill proposes to carve out “medical software” from the definition of “device” in Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321) (“the Act”), medical software would be subject to the same regulatory requirements as medical devices under the Act. In contrast, “clinical software” and “health software” would not be subject to regulation under the Act.
The bill defines medical software as software intended for human or animal use that is intended to be marketed (1) “to directly change the structure or any function of the body of man or other animals;” or (2) for “use by consumers and makes recommendations for clinical action that (i) includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider; and (ii) if followed, would change the structure or any function of the body of man or other animals. . . .” Medical software does not include software “whose primary purpose is integral to the functioning of a drug or device” or software that is a “component of a device;” such software presumably would continue to be regulated as part of the “parent” device or drug product.
Continue Reading House to Consider Bill Excluding Clinical and Health Software from Regulation as Medical Devices