Reforms to Regulations on Medical Devices Software

The Regulatory Affairs Professionals Society magazine, RAPS, ran an important story on rules removing certain kinds of software from medical device regulations. The new rules were enacted by the Food and Drug Administration (FDA) and affects software used to display, store or transfer clinical laboratory tests. The reforms came into force on April 19. 

The 21st Century Cures Act was enacted on December 13, 2016. According to section 3060(a) of the act, “Clarifying Medical Software Regulation,” the Federal Food, Drug, and Cosmetic Act (FD&C Act) was amended, with section 520(o) being added to its text. Section 520(o) defines the software features which would result in certain kinds of medical devices software being excluded from the definition of device articulated in 201(h) of the FD&C Act. In addition to that, section 3060(d) of the Cures Act was used to amend section 201(h) of the FD&C Act so that “device” could no longer be used to apply to software whose functions excluded them from the definition of device as per section 520(o). 

The action taken by the FDA is intended to align regulations to the, which governs medical software provisions and came into force on December 13 2016. Prior to the reforms, medical devices as defined by the encompassed the kind of software that is now outside the ambit of the regulations. The reforms also redefines devices to exclude software used to promote healthy lifestyle choices. 

Medical devices are identified by eight classification regulations. The reforms amend the descriptions within those regulations in such a way that medical devices already excluded by the Cures Act from the definition used within the FD&C Act, are excluded from existing regulations. This harmonises the regulations with the Cures Act, while reflecting the FDA’s authority. 

In order to help the public understand the reforms, the FDA published guidance explaining the reforms resulting from the Cures Act. The guidance explains the changes made pre-existing guidance documents relating to the regulation of medical device software whose functions are described in section 520(o)(1)(A)–(D) of the FD&C Act. As aforementioned, this section describes medical device software whose functions mean that they are excluded from the definition of device as laid out in 201(h) of the FD&C Act. The guideline, however, does explain that under certain circumstances, that medical device software can be considered as medical devices. This is detailed in section 3060. 

Reforms have been in the works for a long time. In May 2018, the public was consulted by the FDA regarding the pros and cons of medical device software that had been removed from the definition of medical device by the Cures Act. 

The reforms do not affect hardware, they are targeted at eight categories of medical devices software. The market for medical devices has exploded. Just as you fill up Go Mini’s portable storage pods with medical devices for sale, you’d have to empty it out. The reforms go a long way to rationalizing regulations and harmoning rules at a time of great uncertainty.