Medical Genetics— FDA advisory panel MG

Medical genetics is the youngest and by far the smallest advisory panel in the 510(k) record, and its near-emptiness is itself the finding. Most genetic and genomic testing reaches patients through routes that never touch this register: laboratory-developed tests run under CLIA, tumor-profiling panels approved via PMA, and novel germline tests that arrived through De Novo classification — the direct-to-consumer genetic-risk authorizations being the best-known examples.

What does file here is the trailing edge of that history: once a De Novo creates a genetics classification regulation, later devices of the same type can clear against it via 510(k), and those follow-on clearances land in this panel. The panel is therefore best read as an early-stage index of which genetic-test categories have matured into routine, predicate-based regulation — sparse today, and worth rechecking precisely because any growth in it marks a category crossing that maturity line.