Genetic database software as medical devices.
PMID: 30311376 · 2018
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Resumo
This article provides a primer on medical device regulations in the United States, Europe, and Canada. Software tools are being developed and shared globally to enhance the accessibility and usefulness of genomic databases. Interactive software tools, such as email or mobile alert systems providing variant classification updates, are opportunities to democratize access to genomic data beyond laboratories and clinicians. Uncertainty over the reliability of outputs, however, raises concerns about
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