27 Sep, 2019

US FDA Final and update guidances – Software

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: 

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