Industry News

Improvements made to FDA medical device recall databases

Improvements to public databases are expected to increase and improve access to safety information on marketed medical devices, according to a press release from the U.S. Food and Drug Administration’s Center for Devices and Radiological Health.

The 510(k) and premarket approval databases will now feature a Center for Devices and Radiological Health recalls hyperlink at the bottom of a record if there are recalls associated with that medical device.

Also, the recalls database has been expanded to include recall status, product classification, premarket submission numbers associated with the recall and the cause of the recall, as determined by the FDA, the release said.

In addition, two new links are available at the bottom of recall records. The first searches the Total Product Lifecycle database for information regarding other devices with the same product code as the recalled device. The other searches the premarket databases for other premarket submissions of this type of product from the same applicant, according to the release.

Improvements to public databases are expected to increase and improve access to safety information on marketed medical devices, according to a press release from the U.S. Food and Drug Administration’s Center for Devices and Radiological Health.

The 510(k) and premarket approval databases will now feature a Center for Devices and Radiological Health recalls hyperlink at the bottom of a record if there are recalls associated with that medical device.

Also, the recalls database has been expanded to include recall status, product classification, premarket submission numbers associated with the recall and the cause of the recall, as determined by the FDA, the release said.

In addition, two new links are available at the bottom of recall records. The first searches the Total Product Lifecycle database for information regarding other devices with the same product code as the recalled device. The other searches the premarket databases for other premarket submissions of this type of product from the same applicant, according to the release.