Medical Device Software Regulatory

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 (typically mobile apps) that transform a mobile platform into a regulated medical device and therefore are the focus of the FDA's regulatory oversight: These mobile apps use a ...

Software as a Medical Device (SaMD) | FDA

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

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 Software as a Medical Device framework provides harmonized quality management principles for the FDA, along with other regulators, to adopt based …

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

SaMD is software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case) it's the software itself that …

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

This guidance was revised through a minor update to reflect amended medical device classification regulations following the issuance of the final rule, …

Software as a Medical Device (SaMD): EU/US …

https://www.emergobyul.com/resources/software-medical-device-samd-euus-regulatory-considerations

Fitzgerald has extensive experience with regulatory strategy for the U.S. and EU and has compiled many U.S. submissions, including 510 (k)s, emergency use authorizations …

Overview of Device Regulation | FDA

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

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling …

Software as a medical device: Here's how the regulatory …

https://www.medicaldesignandoutsourcing.com/software-as-a-medical-device-heres-how-the-regulatory-landscape-is-changing/

To meet that challenge, the FDA has initiated a pilot program, the Digital Health Software Precertification Program, to provide more streamlined and efficient …

Software as Medical Device: …

https://www.johner-institute.com/articles/software-iec-62304/software-as-medical-device/

Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the …

Regulatory Challenges with Software as a Medical Device in EU …

https://www.celegence.com/regulatory-challenges-software-medical-device-mdsw-eu-mdr/

The European Commission’s Medical Device Coordination Group (MDCG) unveiled a Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – …