Regulatory References (FDA Primary Sources)

Status: Living reference list
Last reviewed: 2026-02-10

This list captures FDA primary-source documents/pages used to shape the quality doc set. It is not legal advice.

Software, Cybersecurity, and Interoperability

Content of Premarket Submissions for Device Software Functions (Final, June 2023)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions (Final, February 2026)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket
Cybersecurity in Medical Devices FAQs (section 524B context, SBOM, patches)
https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity-medical-devices-frequently-asked-questions-faqs
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (Final, September 2017)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-and-pre-market-submission-recommendations-interoperable-medical-devices
General Principles of Software Validation (Final, January 2002)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation

Applying Human Factors and Usability Engineering to Medical Devices (Final, February 2016)
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices
Human Factors and Medical Devices (FDA program page)
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/human-factors-and-medical-devices

Investigational Device Exemption (IDE) overview
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide
IDE approval process
https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process
IDE regulations index (21 CFR 812, 50, 56, 54, etc.)
https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-regulations

Quality Management System Regulation (QMSR) page (effective February 2, 2026)
https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr
QMSR frequently asked questions
https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked
Design Controls inspection guidance (21 CFR 820 design-control context)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/design-controls

These references support maintaining a traceable documentation system with: