USFDA Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software
Australia TGA: Regulation of Software based Medical Devices
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain
Australia's TGA: Guidance on Regulation of Software based Medical Devices
UK's MHRA Guidance: Software & AI as a Medical Device Change Programme
USFDA Guidance: Six Finalized Medical Devices Guidelines
USFDA: Office of New Drugs Research Program & Guidance - Software Assurance for Production & Quality
UK MHRA's Guidance: Software Applications (apps)
Draft Guidance for Device Software in Premarket Submissions - USFDA
Regulation & Re-classification of Software based Medical Devices - TGA Australia