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Oct. 20, 2017

Vol. 14 No. 203

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OptiScan Biomedical's OptiScanner 5000 Receives 510(k) Clearance

The device previously won CE Mark certification for use in the EU.  Read More

Canada Proposes Significant Hike in User Fees for Devices

Some of the proposed new fees are dramatically higher than current fees. Read More

Viveve Wins Approval for Viveve System in Mexico

The company plans to submit an investigational device exemption to the FDA to conduct a pivotal trial. Read More

FDA Warns Kelyniam Global for GMPs, Unapproved Products

The inspection revealed that the firm lacked CAPA procedures. Read More