This is a collection of regulatory, guidance and standards documents relevant for the development of Software-Only Medical Devices in the United States.
"($)" Denotes content is not freely available.
- 21 CFR Part 820: QUALITY SYSTEM REGULATION
- 21 CFR Part 11: Electronic Records and Electronic Signatures
- 21 CFR Part 803: Medical Device Reporting
- 21 CFR Part 806: Medica Devices; Reports of Corrections and Removals
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)
- Off-The-Shelf Software Use in Medical Devices (2019)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2018; Draft)
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (2017)
- Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (2005)
- Applying Human Factors and Usability Engineering to Medical Devices (2016)
- List of Highest Priority Devices for Human Factors Review (2016; draft)
- Deciding When to Submit a 510(k) for a Change to an Existing Device (2017)
- Design Control Guidance For Medical Device Manufacturers (1997)
- Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions (2017)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (2014)
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions (2016)
- FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals (2017)
- General Principles of Software Validation (2002)
- Part 11, Electronic Records; Electronic Signatures - Scope and Application (2003)
- Guide To Inspections Of Medical Device Manufacturers (1997)
- Guide To Inspections of Quality Systems aka QSIT (1999)
- Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (2019)
- Medical Device Reporting for Manufacturers (2016)
- Postmarket Management of Cybersecurity in Medical Devices (2016)
- Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions (2019)
- Refuse to Accept Policy for 510(k)s (2019)
- Software as a Medical Device (SAMD): Clinical Evaluation (2017)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)
- Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions (2019; draft)
- Software as a Medical Device (SaMD): Key Definitions (2013)
- Software as a Medical Device (SaMD): Application of Quality Management System (2015)
- Software as a Medical Device (SaMD): Clinical Evaluation (2016)
- ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes ($)
- ISO 14971:2019 Medical devices — Application of risk management to medical devices ($)
- ISO 19011:2018 Guidelines for auditing management systems ($)
- IEC 62304:2006 Medical device software — Software life cycle processes ($)
- IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices ($)
This work has been partially funded by the following NIH grants:
- R42CA183150
- R42AG062026