Posted 19 April 2021 | By
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.”
The agency issued guidance on changes to existing medical software policies resulting from the 21st Century Cures Act in September 2019.
And in May 2018, the FDA launched a public consultation on the benefits and risks of certain medical device software excluded from the definition of a medical device under the 21st Century Cures Act. (RELATED: FDA begins consultation on software excluded from definition of device, Regulatory Focus 29 May 2018)
The agency said that while the rulemaking affects eight software systems, the regulatory status of device hardware will remain unchanged.
The software systems that will no longer be regulated as devices include: Calculator/data processing modules that maintain and retrieve laboratory data, continuous glucose monitor secondary displays, automated indirect immunofluorescence microscopes, medical device data systems, home uterine monitors, medical image storage devices, medical image communication devices and picture archiving and communication systems.
The agency described its rationale used to remove these systems from the medical device regulations in the rulemaking.
The rule went into effect the same day it was published, on 19 April.
Federal Register
© 2021 Regulatory Affairs Professionals Society.
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.”
The agency issued guidance on changes to existing medical software policies resulting from the 21st Century Cures Act in September 2019.
And in May 2018, the FDA launched a public consultation on the benefits and risks of certain medical device software excluded from the definition of a medical device under the 21st Century Cures Act. (RELATED: FDA begins consultation on software excluded from definition of device, Regulatory Focus 29 May 2018)
The agency said that while the rulemaking affects eight software systems, the regulatory status of device hardware will remain unchanged.
The software systems that will no longer be regulated as devices include: Calculator/data processing modules that maintain and retrieve laboratory data, continuous glucose monitor secondary displays, automated indirect immunofluorescence microscopes, medical device data systems, home uterine monitors, medical image storage devices, medical image communication devices and picture archiving and communication systems.
The agency described its rationale used to remove these systems from the medical device regulations in the rulemaking.
The rule went into effect the same day it was published, on 19 April.
Federal Register
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