In vitro diagnostic (IVD) device studies, frequently asked questions.
| Other author | Center for Devices and Radiological Health (U.S.) |
| Other author | Center for Biologics Evaluation and Research (U.S.) |
| Format | Electronic |
| Publication Info | Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2010] |
| Description | 1 online resource (53 p.) : 1 chart. |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS125166 |
| Subjects |
| Variant title | At head of title: Guidance for industry and FDA staff |
| General note | Title from PDF title page (viewed on Aug. 12, 2010). |
| General note | "This document supersedes "Guidance for FDA Staff: Regulating In Vitro Diagnostic Device (IVD) Studies," issued December 17, 1999." |
| General note | "Document issued on: June 25, 2010." |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Bibliography note | Includes bibliographical references: (p. 35-38). |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:V 83/2 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |