HSA NGSNGS IVD
NGS IVD is the official HSA identifier for “Requirements for Registration of Next Generation Sequencing (NGS) Based In Vitro Diagnostic Medical Devices”. NGS IVD is the official identifier HSA uses for this instrument.
- Instrument
- NGS
- Full name
- NGS IVD
- Category
- Registration
- Authority source
- English
- Readable HTML
- 13 articles · 1 language version
- Published
- December 2019
- Effective
- —
Open a language version
Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Requirements for Registration of Next Generation Sequencing (NGS) Based In Vitro Diagnostic Medical Devices
HSA guideline (December 2019) on registering NGS-based IVDs: scope across germline, somatic, and tumour-profiling tests; GN-13 Rule 3 risk classification; and the nine requirement areas from interrogated regions of the genome and specimen requirements through library construction, sequencing and data analysis, controls, test reporting, and the pre-clinical (analytical/clinical validation) and clinical studies. Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-4 with each requirement area (sec-4-1 to sec-4-9) as its own anchored block; the workflow diagram labels are page furniture and the validation-study tables are kept as tabular text.
NGS IVD is the official identifier HSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.