Sources

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FDA Guidance and Official Regulatory Resources

1. FDA - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2023) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions

2. FDA - Deciding When to Submit a 510(k) for a Software Change to an Existing Device (2017) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device

3. FDA - Artificial Intelligence and Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (2021) https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-based-software-medical-device-samd-action-plan

4. FDA - Software as a Medical Device (SaMD): Clinical Evaluation Guidance (2017) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/software-medical-device-samd-clinical-evaluation

5. FDA - Applying Human Factors and Usability Engineering to Medical Devices (2016) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices

6. FDA - Medical Device Software (SaMD) - Overview and Resources https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

7. FDA - Pre-Submission Program and Meetings with FDA Staff (Q-Submissions) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program

8. FDA - Design Controls Guidance for Medical Device Manufacturers (1997) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-controls-guidance-medical-device-manufacturers

9. FDA - Postmarket Management of Cybersecurity in Medical Devices (2016) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices

Code of Federal Regulations (21 CFR)

10. 21 CFR Part 820 - Quality System Regulation https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

11. 21 CFR Part 11 - Electronic Records; Electronic Signatures https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11

12. 21 CFR Part 803 - Medical Device Reporting https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803

13. 21 CFR Part 830 - Unique Device Identification https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830

14. 21 CFR Part 807 - Establishment Registration and Device Listing (510(k)) https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807

15. 21 CFR Part 814 - Premarket Approval of Medical Devices (PMA) https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-814

IMDRF and International Harmonization

16. IMDRF - Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations (IMDRF/SaMD WG/N12 FINAL:2014) https://www.imdrf.org/documents/software-medical-device-samd-possible-framework-risk-categorization-and-corresponding

17. FDA Digital Health Center of Excellence https://www.fda.gov/medical-devices/digital-health-center-excellence

18. FDA - Quality Management System Regulation (QMSR) Final Rule (2024) https://www.federalregister.gov/documents/2024/02/23/2024-02052/quality-management-system-regulation