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FDA Unveils Strengthened Medical Device Reporting Database With New Features

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By Alexander Gaffney, RF News Editor

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has unveiled new improvements to its medical device recalls database, allowing members of industry and the public to more easily associate devices and safety recall issues.

Prior to the new database, searches for a device yielded separate results for its labeling/approval information and any recalls. This could be problematic for healthcare providers, who would have no way of knowing if an approved device was associated with any issues, and industry, which might be developing a similar device to an approved predicate but be unaware of prior issues.

The new system will join FDA's Medical Device Recalls Database and its 510(k) premarket notification and premarket approval (PMA) databases.

The benefit, FDA explained, will be that the 510(k) and PMA databases will have embedded hyperlinks that lead directly to any information on recalls associated with a particular medical device.

In addition, the recalls database has also seen a major upgrade, FDA explained.

"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."

Further, a new search option will link up the recalls database with FDA's Total Product Lifecycle (TPLC) database to find other products with the same PMA or 510(k) product code. Similar products often exhibit similar physical defects or safety issues.

Search terms have also been changed slightly, with FDA modifying the "reason for recall" field to now read, "manufacturer reason for recall." FDA said the wording change better reflects the "source of the information," and that it is not necessarily FDA's determination.

Also, the previously available field "Reason for Recall" has been renamed "Manufacturer Reason for Recall" to better clarify the source of the information, FDA said.


FDA Statement




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