Medical Software Regulation

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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

Examples of Device Software Functions the FDA Regulates

https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-device-software-functions-fda-regulates

Software functions that are used in active patient monitoring or to analyze patient-specific medical device data and therefore are the focus of the FDA's regulatory …

Software As a Medical Device: FDA Digital Health Regulation

https://www2.deloitte.com/us/en/pages/public-sector/articles/software-as-a-medical-device-fda.html

The international medical device regulators forum (IMDRF), of which the US FDA is a member, describes SaMD as software that may …

Global Approach to Software as a Medical Device | FDA

https://www.fda.gov/medical-devices/software-medical-device-samd/global-approach-software-medical-device

The IMDRF Quality Management System for Software as a Medical Device (SaMD) framework helps manufacturers and international regulators attain a common …

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 …

A Brief Introduction to the United States Medical …

https://innolitics.com/articles/intro-to-medical-software-regulations/

A Brief Introduction to the United States Medical Software Regulations, for Developers FDA Premarket Submissions. Before you can legally sell most new medical …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, …

Software development for healthcare: ISO standards, regulation ...

https://www.effectivesoft.com/blog/basics-of-software-development-for-healthcare.html

Software as a Medical Device (SaMD) (also called “standalone”). Software embedded in a medical device ensures the proper functioning of a physical medical device or controls it …

Regulation of software based medical devices

https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices

Regulation of software based medical devices Guidance. The purpose of this guidance is to help manufacturers and sponsors understand how the TGA interprets... New …

FDA regulation of medical software - PubMed

https://pubmed.ncbi.nlm.nih.gov/10788227/

Currently the FDA is reviewing its policy on the regulation of computer software in the medical arena. Healthcare practitioners hope that the FDA will take the least possible …

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