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# FDA Wants Software Precertification Test Cases
- URL: https://www.fdaweb.com/fda-wants-software-precertification-test-cases/
- Published: 2019-05-22T12:00:00.000Z
- Updated: 2026-09-15T01:28:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144160

FDA says it is looking for test cases from software organizations planning to submit a de novo request or 510(k) submission for software as a medical device to meet the goals of the software precertification program. An agency [notice](https://www.fda.gov/medical-devices/digital-health-software-precertification-pre-cert-program/digital-health-software-precertification-pre-cert-program-participate-2019-test-plan?utm%5Fcampaign=Test%20Case%20Volunteers%20for%20the%20Test%20Plan%20for%20the%20Software%20Precertification%20Program&utm%5Fmedium=email&utm%5Fsource=Eloqua) says volunteers are sought representing a broad spectrum of software developers: small and large software development firms; companies that develop a range of products, including both low- and high-risk software as a medical device; and companies that are not considered to be traditional medical device manufacturers but who intend to make software as a medical device.

The notice gives application instructions and selection qualities.