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# Guide on Device Software Policy Changes
- URL: https://www.fdaweb.com/guide-on-device-software-policy-changes/
- Published: 2019-09-27T12:00:00.000Z
- Updated: 2026-09-15T01:52:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145112

*Federal Register* notice: FDA has made available a final guidance on “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.” The guidance provides the agency’s current thinking on changes made by the act to the definition of a medical device and the resulting effect on guidances related to medical device software. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-27/pdf/2019-21001.pdf?ref=fdaweb.com).