FDA Publishes 4 Draft Guidances In Continuing Effort To Modernize 510(k)

FDA Publishes 4 Draft Guidances In Continuing Effort To Modernize 510(k)

FDA Logo

FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway.

Sourced through Scoop.it from: www.mpo-mag.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

Leave a Reply

Your email address will not be published. Required fields are marked *