In vitro diagnostic (IVD) device studies, frequently asked questions.
| Corporate Authors: | Center for Devices and Radiological Health (U.S.), Center for Biologics Evaluation and Research (U.S.) |
|---|---|
| Format: | Government Document eBook |
| Language: | English |
| Published: |
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,
[2007]
|
| Subjects: | |
| Online Access: | https://purl.fdlp.gov/GPO/LPS112196 |
Similar Items
In vitro diagnostic (IVD) device studies, frequently asked questions.
Published: (2010)
Published: (2010)
Assay migration studies for in vitro diagnostic devices.
Published: (2009)
Published: (2009)
In vitro methods in toxicology /
Published: (1987)
Published: (1987)
In vitro toxicity indicators /
Published: (1994)
Published: (1994)
In vitro and non-mammalian testing methods for determining organophosphate insecticide toxicity /
by: Britt, Janice Kay, 1964-
Published: (1990)
by: Britt, Janice Kay, 1964-
Published: (1990)
Biological evaluation of medical devices. Évaluation biologique des dispositifs médicaux. Partie 5, Essais concernant la cytotoxicité in vitro.
Published: (2009)
Published: (2009)
Biocompatibility protocols for medical devices and materials /
Published: (2023)
Published: (2023)
Biocompatibility protocols for medical devices and materials /
Published: (2023)
Published: (2023)
Toxicology in vitro.
In vitro toxicity testing of environmental agents : current and future possibilities /
Published: (1983)
Published: (1983)
Introduction to in vitro cytotoxicology : mechanisms and methods /
by: Barile, Frank A.
Published: (1994)
by: Barile, Frank A.
Published: (1994)
Toxicity assessment alternatives : methods, issues, opportunities /
Published: (1999)
Published: (1999)
Cell culture methods for in vitro toxicology /
Published: (2001)
Published: (2001)
In vitro methods in aquatic toxicology /
Published: (2003)
Published: (2003)
In vitro diagnostic devices : guidance for the preparation of 510(k) submissions /
by: Bracey, Alfred
Published: (1987)
by: Bracey, Alfred
Published: (1987)
Functional foods and beverages : in vitro assessment of nutritional, sensory, and safety properties /
Published: (2018)
Published: (2018)
In vitro effects of mineral dusts : third international workshop /
Published: (1985)
Published: (1985)
Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process.
Published: (2008)
Published: (2008)
Classification names for medical devices and in vitro diagnostic products /
Published: (1991)
Published: (1991)
In vitro effects of mineral dusts : third international workshop /
Published: (1985)
Published: (1985)
Usability testing of medical devices /
by: Wiklund, Michael E.
Published: (2011)
by: Wiklund, Michael E.
Published: (2011)
Developmental toxicity evaluation of diacetoxyscirpenol /
by: Smith, Ernest Edison
Published: (1989)
by: Smith, Ernest Edison
Published: (1989)
Trends in development of medical devices /
by: Shanmugam, Prakash Srinivasan Timiri
Published: (2020)
by: Shanmugam, Prakash Srinivasan Timiri
Published: (2020)
Better health care with quality medical devices : FDA on the cutting edge of device technology.
Published: (2002)
Published: (2002)
Health devices.
H.R. 1346, the Medical Device Safety Act of 2009 : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, May 12, 2009.
Published: (2011)
Published: (2011)
H.R. 1346, the Medical Device Safety Act of 2009 : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, May 12, 2009.
Published: (2011)
Published: (2011)
Biological evaluation of medical devices. Évaluation biologique des dispositifs médicaux. Partie 6, Essais concernant les effets locaux après implantation.
Published: (2007)
Published: (2007)
Use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use.
Published: (2004)
Published: (2004)
WHO global model regulatory framework for medical devices including in vitro diagnostic medical devices.
Published: (2017)
Published: (2017)
FDA medical device approval : is there a better way? : hearing before the Subcommittee on Health Care, District of Columbia, Census, and the National Archives of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Twelfth Congress, first session, June 2, 2011.
Published: (2011)
Published: (2011)
FDA medical device approval : is there a better way? : hearing before the Subcommittee on Health Care, District of Columbia, Census, and the National Archives of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Twelfth Congress, first session, June 2, 2011.
Published: (2011)
Published: (2011)
Developmental toxicities of aflatoxins B₁ and G₁ : in vivo and in vitro assessments /
by: Maull, Elizabeth Anne
Published: (1988)
by: Maull, Elizabeth Anne
Published: (1988)
Effects of mineral dusts on cells /
Published: (1989)
Published: (1989)
In vitro biological systems /
Published: (1993)
Published: (1993)
Biological evaluation of medical devices. Evaluation biologique des dispositifs médicaux. Partie 1, Evaluation et essais au sein d'un processus de gestion du risque.
Published: (2009)
Published: (2009)
Developmental toxicity and structure-activity relationships of ochratoxin A and related compounds in Hydra attenuata /
by: Taylor, Monica Ann, 1961-
Published: (1988)
by: Taylor, Monica Ann, 1961-
Published: (1988)
In vitro toxicity testing protocols /
Published: (1995)
Published: (1995)
New microbiotests for routine toxicity screening and biomonitoring /
Published: (2000)
Published: (2000)
In vitro toxicology : a progress report from the Johns Hopkins Center for Alternatives to Animal Testing /
Published: (1985)
Published: (1985)