FDA Releases Key Guidance Updates

Below you can find a list of the updated documents with the respective links:

US FDA Guidance: Clinical Decision Support Software (Jan 2026)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software

US FDA Guidance: Low risk wellness devices (Jan 2026)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices

US FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (Dec 2025)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices

US FDA Draft Guidance: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products (Jan 2026)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-bayesian-methodology-clinical-trials-drug-and-biological-products