FDA Announces Improvements To The Medical Device Recalls Database (FDA)
Today, the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is pleased to announce improvements to several public databases that will increase access to safety information on marketed medical devices. The improvements include adding new fields to the Medical Device Recalls database and providing links to the recall database from FDA’s 510(k)Premarket Notification andPremarket Approval (PMA) databases.
Specifically:
The 510(k) and PMA databases will have a CDRH Recalls hyperlink at the bottom of each record if there are recalls associated with that medical device.
The recalls database has been expanded to include recall status (whether or not the recall has been terminated), product classification (product code), premarket submission numbers associated with the recall (510(k)s and PMAs only), and the root cause of the recall as determined by the FDA. Also, the previously available field "Reason for Recall" has been renamed "Manufacturer Reason for Recall" to better clarify the source of the information.
In addition to the new and renamed fields, two new links are availa...
