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Equipment and Method Selection

Availability of Methods

A catalog of cleared and approved medical device information from the FDA. It includes links to the device summary information, manufacturer, approval date, user instructions, and other consumer information. Devices@FDA searches the following databases: PMN-510(k) Premarket Notification; PMA-Premarket Approval; and HDE-Humanitarian Device Exemption.

Last Updated on Wednesday, 31 July 2013 11:10

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Validation Methods

Validation of Laboratory-Developed Molecular Assays for Infectious Diseases: 
Molecular tests to detect infectious agents are now widely used in many clinical laboratories. In spite of their widespread use, there is confusion surrounding the requirements that need to be met when bringing a molecular test, whether FDA approved/cleared or laboratory developed, into a clinical laboratory. This review presents information that laboratories may consider in their efforts to meet regulatory requirements.

Last Updated on Monday, 16 November 2015 12:42

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