FDA Issues Final Guidance For Humanitarian Device Exemption Program

FDA Issues Final Guidance For Humanitarian Device Exemption Program

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” For a device to be eligible for an HDE, the FDA must determine that the device would not be available to a person with a given disease or condition without the HDE approval. Further, the agency must establish that there is no comparable device available to treat or diagnose the disease or condition, other than another device approved under an HDE or IDE.”

Sourced through Scoop.it from: www.360dx.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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