Decision Support Systems are also increasingly being used in medicine. If they are medical devices, they must meet the legal requirements (e.g., the general safety and performance requirements). The hype surrounding Artificial Intelligence, in particular Machine Learning, and users such as Watson are raising hopes for the performance of Decision Support Systems. This article presents…
DetailsFrom 2017-2022 the FDA offered a “Precertification (Pre-Cert) Pilot Program” to specific companies for standalone software to simplify and accelerate the approval process for digital health devices. This article summarizes the most important aspects and provides a quick overview. Precertification (Pre-Cert) Pilot Program The FDA has recognized that software The new approach The agency is,…
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