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CDRH Prepares For Electronic Recall Submissions; Pre-Market Still A Challenge

Device recall reports may be submitted via FDA’s eSubmitter platform beginning in the coming months. Meanwhile, full-fledged electronic submissions of pre-market device applications are still a ways off.

FDA will begin to accept electronic submissions of device recall actions in the next several months, but it will still be some time until most pre-market device submissions can be made online, according to a staffer at the device center.

Currently, device makers submit correction and removal reports for products to an FDA district office in paper format. The reports...

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