The U.S. Food and Drug Administration, Center for Devices and Radiological Health, has announced improvements to the medical device recalls database.
The following three improvements will improve access to safety information on marketed medical devices, according to the FDA.
1. The 510(k) Premarket Notification and Premarket Approval databases will offer a hyperlink with a recall record if a device has recalls attached to it.
2. The recall database will now include the following categories: recall status, product classification, premarket submission numbers and the cause of the recall. Additionally, the "Reason for Recall" category has been renamed "Manufacturer Reason for Recall" to clarify the source of information.
3. Recall records will now have links to search two new databases: the Total Product Lifecycle database to give information on products with the same product code as the recalled product, and the premarket databases for other submissions of similar products by the same applicant.
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