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# Stakeholder Comments on 21st Century Cures Software
- URL: https://www.fdaweb.com/stakeholder-comments-on-21st-century-cures-software/
- Published: 2018-07-18T12:00:00.000Z
- Updated: 2026-09-15T00:20:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141908

GE Healthcare calls on FDA to continue to employ a risk-based approach to regulating software products, differentiating not only between functions that are not medical devices and those that remain medical devices, but also including a category of products that, based on risk, warrant exercising enforcement discretion. The company’s [comment](https://www.regulations.gov/document?D=FDA-2018-N-1910-0023&ref=fdaweb.com) is in response to the agency’s request for input on regulation of software under the 21st Century Cures Act. “We request that the agency considers in such determination the situations where potential risk is mitigated by a trained clinician exercising their professional judgment and expertise to independently assess and consider or discard the recommendation made by an algorithm. This would also be consistent with the long-established FDA regulatory classification methodology based on the intended use and risk of the product.”

The ECRI Institute [says](https://www.regulations.gov/document?D=FDA-2018-N-1910-0021&ref=fdaweb.com) digital health technologies pave the way for better, safer, and more efficient care. However, it says, like other technologies, health IT presents unintended consequences that may contribute to patient harm. “Safety concerns involve the technology itself as well as its implementation and use,” it says. “We urge FDA and the federal government more generally to encourage an overarching, non-regulatory safety framework as it works on its report required under the Cures Act.”

AMIA [submits](https://www.regulations.gov/document?D=FDA-2018-N-1910-0018&ref=fdaweb.com) for FDA consideration its preliminary review of relevant research into the specific benefits and risks to health associated with each of the software functions excluded by the Cures Act. “While not exhaustive,” it says, “the evidence to date suggests a wide array of potential benefits as well as an assortment of emerging risks to personal health and safety.”

Becton, Dickinson [presents](https://www.regulations.gov/document?D=FDA-2018-N-1910-0011&ref=fdaweb.com) the risks and benefits of software used for administrative support of a healthcare facility, general wellness products, electronic patient records, medical device data systems, and clinical decision support.

Finally, the Consumer Technology Association [says](https://www.regulations.gov/document?D=FDA-2018-N-1910-0009&ref=fdaweb.com) FDA has thus far achieved an appropriate balance in ensuring that software service medical purposes is adequately regulated, while manufacturers are not overburdened by excessive requirements that hinder innovation and do not enhance patient/user safety. The group says it believes that the risks posed by software functions that the Cures Act excluded from the medical device definition are relatively minor and/or adequately mitigated, and do not warrant any modifications to the updated regulatory paradigm for such products. At the same time, it says, the potential benefits of software functions falling into the excluded categories, particularly given the growing number of people in the U.S. requiring healthcare services and the increasing costs of such services, are tremendous.