The guidance outlines manufacturer’s responsibilities for reporting adverse events to FDA. Unless exempted, manufacturers must implement written procedures addressing Medical Device Reporting (MDR) requirements. Guidelines for follow-up investigations and addressing event reports in the medical or scientific literature are included.
The device guidance updates FDA requirements for determining when a 510(k) premarket notification is required for device changes. It offers principles and flow charts for assessing label changes, and assessing technology, engineering, performance, and materials changes for in vitro diagnostic and non-IVD devices. Also included are risk assessment considerations, case examples with explanations why a 510(k) is or is not needed, and documentation required if a 510(k) is not needed. The software guidance focuses on how to determine when a software change requires filing a 510(k).
The device guidance updates FDA requirements for determining when a 510(k) premarket notification is required for device changes. It offers principles and flow charts for assessing label changes, and assessing technology, engineering, performance, and materials changes for in vitro diagnostic and non-IVD devices. Also included are risk assessment considerations, case examples with explanations why a 510(k) is or is not needed, and documentation required if a 510(k) is not needed. The software guidance focuses on how to determine when a software change requires filing a 510(k).
To reduce the risk of harm due to evolving cybersecurity threats, manufacturers of medical devices that use software or programmable directions should develop an ongoing program to identify, assess, and mitigate new risks.
This guidance provides principles of human factor engineering and how to apply them in combined medical products that contain drug and device components. Priority review draft guidance lists device categories requiring human factor review, and outlines FDA’s approach for determining if a product filing requires human factor data.
This guidance outlines when real-world evidence (RWE) derived from non-traditional data sources, such as electronic medical records and registries, can be used to support regulatory decisions for new or updated devices.
