FDA Announces Faster Device Recall Information

FDA-CDRH announced that it is posting recall information earlier than it had before. In the prior approach, the manufacturer would initiate a correction or removal under Part 806, notify FDA, and FDA would classify the resulting recall. In the new approach, FDA adds the information to the database before the recall classification.

The URL for the search engine is https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?source=govdelivery&utm_medium=email&utm_source=govdelivery

The manufacturer still submits the Part 806 information to the District Recall Coordinator, who will ask whether the information is ready to post in the database. If the information is ready, FDA-CDRH will post it.

A note for a typical entry says, “A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.”