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CDRH Extends Device Establishment Registration Deadline

The device center has extended the annual medical device registration period by one month to Jan. 31, as companies and FDA adopt new registration and registration fee requirements established in the FDA Safety and Innovation Act and recent regulatory revisions.

CDRH has extended the deadline to Jan. 31 for medical device manufacturers to register and list their devices with the agency. The original deadline of Dec. 31 is being bypassed to allow for newly covered contract manufacturers and sterilizers of finished devices, as well as foreign manufacturers, to register and list their devices with FDA.

With the one-month extension of the fiscal 2013 annual registration period, manufacturers may now renew their registration through Jan. 31...

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