Thermo Fisher Scientific announced that its San Jose, California facility has registered with the U.S. Food and Drug Administration (FDA) as a medical device establishment. 

“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.