Deciding When to Submit a 510(k) for a Software Change to an Existing Device (FDA)

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).

Deciding When to Submit a 510(k) for a Change to an Existing Device (FDA)

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).

Postmarket Management of Cybersecurity in Medical Devices (FDA)

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.

Human Factors Studies and Related Clinical Study Considerations in Combination  Product Design and Development (FDA)

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 Priority review draft guidance lists device categories requiring human factor review, and outlines FDA’s approach for determining if a product filing requires human factor data.

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (FDA)

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.

Adaptive Designs for Medical Device Clinical Studies (FDA)

Guidance on planning and implementing adaptive designs for clinical studies used in medical device development. It includes definitions, when to choose adaptive designs, using adaptive designs in blinded and unblinded studies, examples of various adaptive designs and potential challenges. Also recommends consulting with FDA in developing adaptive trials, and applies to PMA, 510(k), de novo, humanitarian, and investigational device exemption submissions at all trial stages.