This morning, the FDA published its 17-page first draft of a working model for its pre-certification program for software as a medical device (SaMD). Though still preliminary (the agency is asking for ...
The FDA unveiled new updates on the ongoing Pre-Cert program including a Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model. One of the big take aways from ...
The FDA initiative, led by Patel, seeks to reduce certification hurdles for developers of software-based medical devices by shifting responsibility for periodic software updates to manufacturers ...
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