Regulations.gov document
Considerations for Design, Development, and Analytical Validation of Next Generation…
Other · FDA-2016-D-1270 · posted Apr 17, 2018
Key facts
| Document ID | FDA-2016-D-1270-0041 |
|---|---|
| Title | Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases Guidance for Stakeholders and Food and Drug Administration Staff |
| Document type | Other |
| Subtype | Guidance |
| Agency | FDA |
| Docket | FDA-2016-D-1270 |
| Posted | Apr 17, 2018 |
| Comment period opens | Apr 17, 2018 |
At a glance
- 10–99 Public comments on this docket
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