FDA Clinical Decision Support SW Draft Guidance

On Dec. 8, 2017 FDA released a Draft guidance “Clinical and Patient Decision Support Software”. This guidance addresses software for decision support in two categories: one used by Healthcare Professionals, the other used personally by patients and non-health professionals. It provides FDA interpretation of which types of Decision Support Software do not meet the definition of a medical device (as modified in the 21st Century Cures Act), which types may meet the definition, and which types FDA will focus on in terms of regulatory oversight. One key factor is whether the information provided by the software can be indepently evaluated by the Cinician. The full guidance is at the link provided. Clinical and Patient Decision Support Software

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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