USA – FDA issues final rule removing certain software from medical device regulations

The US Food and Drug Administration (FDA) has issued a final rulemaking that eliminates certain software intended to transfer, store or display clinical laboratory tests from being regulated as medical devices.

This action was taken to conform to the medical software provisions of the 21st Century Cures Act, enacted on 13 December 2016. The law amended the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act) to exclude such software; the law also removes software that encourages a healthy lifestyle from medical device regulations.

The agency announced that “with this final rule, FDA is amending the ‘identification’ description of eight classification regulations so that the regulations no longer include software functions that the Cures Act excluded from the device definition in the FD&C Act. In other words, FDA is amending eight classification regulations so that the regulations conform to the medical software provisions of the Cures Act and reflect FDA’s current statutory authority.”…