NEW YORK (GenomeWeb) – Thermo Fisher Scientific today said that its San Jose, Calif., facility has been registered with the US Food and Drug Administration as a medical device establishment.
As a result, the facility will be able to design and manufacture devices for analyzing samples from patients for in vitro diagnostic uses. The San Jose site achieved ISO 13485 certification last year, and FDA registration "is the next major milestone in our ongoing initiative to develop Class I mass spectrometry-based instruments for the clinical market," Thermo Fisher President of Chromatography and Mass Spectrometry Dan Shine said in a statement.
Firms that have mass spec instruments registered as Class I medical devices with FDA include Waters, Agilent, and Danaher's AB Sciex. In 2011 the agency began requiring that manufacturers register instruments intended for use in a clinical setting.