Thermo Fisher Scientific Registers San Jose Facility with FDA

Thermo Fisher Scientific today announced that its San Jose, California facility has registered with the U.S. Food and Drug Administration (FDA) as a medical device establishment. The site has established a quality in accordance with the FDA Quality System Regulations to design and manufacture devices for analyzing samples from patients for in vitro diagnostic use.

“Last year we achieved ISO 13485 certification for the San Jose site, and this FDA registration is the next major milestone in our ongoing initiative to develop Class 1 mass spectrometry-based instruments for the clinical market,” said Dan Shine, president, chromatography and mass spectrometry, Thermo Fisher Scientific.