Fda Software Guidance For Medical Devices

Software as a Medical Device (SaMD) | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

Given the unique features of Software as a Medical Device that extend beyond a traditional medical device or hardware, regulators across the globe recognized the need to converge on a common framework and principles for Software as a Medical Device that enables all stakeholders, including regulators, to … See more

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices

Center for Devices and Radiological Health This guidance document is intended to provide information to industry regarding the documentation that we recommend you include in …

Policy for Device Software Functions and Mobile Medical …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications

Center for Biologics Evaluation and Research FDA is issuing this guidance to communicate how the Agency intends to apply its regulatory oversight to certain …

Device Software Functions Including Mobile Medical …

https://www.fda.gov/medical-devices/digital-health-center-excellence/device-software-functions-including-mobile-medical-applications

How does the FDA regulate device software functions? The FDA applies the same risk-based approach to device software functions as the agency uses to …