According to an FDA news release posted on December 16, 2013, the U.S. Food and Drug Administration (“FDA”) has made improvements to several public databases in an effort to increase access to safety information for medical devices.
The following changes have been implemented:
- The 510(k) and PMA databases now have hyperlinks at the bottom of each record if there is a recall associated with that particular medical device.
- The Recalls Database now includes fields for “recall status” (whether or not the recall has been terminated), “product classification” (product code), “premarket submission numbers” (associated with the 510(k) or PMA approval) and “root cause of the recall as determined by the FDA”.
- The field for “reason for recall” has been renamed “manufacturer reason for recall” to better clarify the source of the information.
- Two new links are also available on the bottom of recall records. The first will search the Total Product Lifecycle (TPLC) Database for information regarding other devices with the same product code as the recalled device. The other will search the premarket database for other premarket submissions of this type of product from the same applicant. This will provide information about submissions cleared or approved after the recall.
Read the FDA News Release: