Regulations.gov document
Considerations for Design, Development, and Analytical Validation of Next Generation…
Notice · FDA-2016-D-1270 · posted Apr 13, 2018
Key facts
| Document ID | FDA-2016-D-1270-0040 |
|---|---|
| Title | Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing-Based In Vitro Diagnostics Intended To Aid in the Diagnosis of Suspected Germline Diseases; Guidance for Stakeholders and Food and Drug Administration Staff; Availability |
| Document type | Notice |
| Subtype | Notice of Availability |
| Agency | FDA |
| Docket | FDA-2016-D-1270 |
| Posted | Apr 13, 2018 |
| Federal Register citation | 83 FR 16106 |
| FR document number | 2018-07687 |
| Comment period opens | Apr 13, 2018 |
| Effective date | Apr 13, 2018 |
At a glance
- 1–9 Pages
- 10–99 Public comments on this docket
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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