Final and update guidances – Software
… the FDA is issuing a final guidance, Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act. This guidance details the changes to existing guidance documents that relate to the regulation of the software functions. As such, the FDA updated the following final guidances to ensure consistent policy in the regulation of digital health products:
- Policy for Device Software Functions and Mobile Medical Applications (originally titled Mobile Medical Applications)
- General Wellness: Policy for Low Risk Devices
- Off-The-Shelf Software Use in Medical Devices
- Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
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