Digital Health 25
- Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices (DRAFT)
- Predetermined Change Control Plans for Artificial Intelligence and Machine Learning-Enabled Device Software Functions
- Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
- Technical Considerations for Physiologic Closed-Loop Control Medical Devices
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Medical Device Development Tools (MDDT) Qualification Program
- Content of Premarket Submissions for Device Software Functions
- Policy for Device Software Functions and Mobile Medical Applications
- Medical Device Data Systems, Medical Image Storage, and Medical Image Communications Devices - Policy for Functionality and Regulatory Status
- Clinical Performance Assessment of Computer-Assisted Detection Devices in Radiology
- Clinical Decision Support Software Functions: Criteria for Non-Device Classification and Implementation Requirements
- Computer Software Assurance for Production and Quality System Software (DRAFT)
- Multiple Function Device Products: Policy and Considerations for Functions Not Subject to FDA Review
- General Wellness Products: Policy for Low Risk Devices and Software Functions
- Changes to Medical Device Definition for Software Functions Under the 21st Century Cures Act
- Distribution of LOINC Codes for In Vitro Diagnostic Tests by Manufacturers
- Medical Device Accessories: Classification and Risk-Based Approach
- Deciding When to Submit a New 510k for Software Changes to Medical Devices
- Design Considerations and Recommendations for Interoperable Medical Devices
- Postmarket Management of Cybersecurity in Medical Devices
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Radio Frequency Wireless Technology in Medical Devices
- Cybersecurity for Networked Medical Devices with Off-The-Shelf Software
- Software Validation for Medical Device Production, Quality Systems, and Device Components