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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: CDRH Reports

Reports on Non-Device Software Functions

These reports are published every two years and examine information on any risks and benefits to health associated with non-device software functions described in section 520(o)(1)(A)-(E) of the FD&C Act and provide findings on their impact on patient safety, including best practices.

2024 Report on Non-Device Software Functions (PDF - 1.72 MB)
2022 Report on Non-Device Software Functions (PDF - 1 MB)
2020 Report on Non-Device Software Functions (PDF - 6.7 MB)
2018 Report on Non-Device Software Functions (PDF - 278 KB)

Additional Reports

FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework (2014)

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Additional Reports

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