FDA 510(k) rules let recalled devices beget recalled devices

FDA 510(k) rules let recalled devices beget recalled devices

An analysis found that devices are more likely to face a Class I recall if their FDA authorizations were based on devices that had been recalled, too.

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.

Learn MoreOmnica Corporation

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