Guideline for the Manufacture of in Vitro Diagnostic Products
Title | Guideline for the Manufacture of in Vitro Diagnostic Products PDF eBook |
Author | |
Publisher | |
Pages | 48 |
Release | 1990 |
Genre | Diagnosis, Laboratory |
ISBN |
GMP Guidelines for the Manufacture of in Vitro Diagnostic Products
Title | GMP Guidelines for the Manufacture of in Vitro Diagnostic Products PDF eBook |
Author | Center for Devices and Radiological Health (U.S.) |
Publisher | |
Pages | 28 |
Release | 1988 |
Genre | Medical instruments and apparatus industry |
ISBN |
In Vitro Diagnostic Devices
Title | In Vitro Diagnostic Devices PDF eBook |
Author | Alfred Bracey |
Publisher | |
Pages | 78 |
Release | 1987 |
Genre | Medical instruments and apparatus |
ISBN |
Public Health Effectiveness of the FDA 510(k) Clearance Process
Title | Public Health Effectiveness of the FDA 510(k) Clearance Process PDF eBook |
Author | Institute of Medicine |
Publisher | National Academies Press |
Pages | 141 |
Release | 2010-10-04 |
Genre | Medical |
ISBN | 0309162904 |
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Evaluation of Stability of in Vitro Diagnostic Reagents
Title | Evaluation of Stability of in Vitro Diagnostic Reagents PDF eBook |
Author | James F. Pierson-Perry |
Publisher | |
Pages | 0 |
Release | 2009 |
Genre | Diagnostic reagents and test kits |
ISBN |
"provides guidance and regression-based procedures for establishing stability-related claims on in vitro diagnostic (IVD) reagents such as reagent kits, calibrators, control products, and sample diluents. This guideline was written primarily for manufacturers and regulatory agencies, but will also be of interest to clinincal laboratories"--Cover.
Dietary Supplements
Title | Dietary Supplements PDF eBook |
Author | United States. Federal Trade Commission. Bureau of Consumer Protection |
Publisher | |
Pages | 32 |
Release | 1998 |
Genre | Advertising |
ISBN |
FDA Biotechnology Inspection Guide
Title | FDA Biotechnology Inspection Guide PDF eBook |
Author | United States. Food and Drug Administration |
Publisher | |
Pages | 62 |
Release | 1991 |
Genre | Biotechnology |
ISBN |