FDA Faces Blowback Over Regulating Lab-Developed Tests

FDA Faces Blowback Over Regulating Lab-Developed Tests

Clinical laboratory lobbying groups are suing the FDA over its plans to more strictly regulate lab-developed tests. For now, physicians should see few changes in test availability.

Read the full article at: www.medscape.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.

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