It added that the system 'supports reliable development and implementation of user-defined NGS diagnostic assays in a clinical laboratory and enables 21 CFR Part 11 compliance' - a code of regulations that define the criteria under which electronic signatures are considered trustworthy and equivalent to paper records.

The Ion PGM Dx platform was designed to meet the needs of the clinical laboratory and is intended for targeted sequencing of human genomic DNA using peripheral blood samples, Thermo Fisher said. It also said at the time that it would market the instrument as Ion PGM Dx.įDA categorizes medical devices into three classes, with Class I considered to be low risk and subject to the least regulatory controls and Class III deemed the highest risk devices and subject to the highest level of regulatory control, often requiring agency approval before they can be marketed. NEW YORK (GenomeWeb) – Thermo Fisher Scientific today said that it has completed the listing of the Ion PGM Dx next-generation sequencing system with the US Food and Drug Administration as a Class II medical device.Īs Clinical Sequencing News reported in June, Thermo Fisher planned to register the Ion Torrent PGM with the FDA rather than go through the 510(k) process, as the instrument had the same intended use as Illumina's FDA-cleared MiSeqDx platform. Advances in Clinical Genomics Profiling.

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