The FDA has outlined new details for its Digital Health Software Pre-certification Program, according to the Politico Morning eHealth newsletter. 1. The FDA launched the pre-cert program in 2017 to ...
Regular readers of this blog know that we’re closely following the FDA’s proposed regulatory framework for software as a medical device (SaMD), known as precertification—Pre-Cert for short. Generally, ...
The FDA continues to move at a fast pace to develop and, soon, implement its pre-certification program for medical software development. Yesterday the agency released a second draft of its Pre-Cert ...
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