Clinical lab industry sues to block FDA’s new oversight of lab-developed tests
ACLA said the agency overstepped when it announced it would regulate all in vitro diagnostics with the same approach it uses for medical devices.
Read the full article at: www.fiercebiotech.com
Who We Are
Omnica Corporation is a privately-held design, engineering, and medical product development firm located in Irvine, California. The 28-person company is staffed with full-time employees and has been in operation since 1984. Our speciality is custom product development for the medical industry and industrial fields.
Our expertise is developing complex medical devices.Technical personnel at Omnica includes designers, mechanical engineers, electronic and software engineers, advanced R&D specialists, regulatory staff (for FDA documentation), machinists and model makers.
