FDA updates guidance on exemption of certain medical devices from 510(k) requirements
This exemption of certain unclassified medical devices from 510(k) requirements aims to achieve two goals: decrease regulatory burdens on the medical device industry and reduce costs required to comply with federal regulations, while allowing patients continued access to medical devices.
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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.