A CDRH report recently showed that a majority of recalled devices are older, yet the center has provided little insight into how it came to its conclusion. FDA’s relative silence on the matter has left several industry insiders to deduce for themselves why aging product types struggle more with recalls than younger ones. One such expert believes a failure by manufacturers to understand their own products and evolving international standards play a role in the substantial number of older-device recalls. “I don’t think there’s any one thing you can say is causing this problem,” said Monica Wilkins, divisional VP of QA/RA for device-maker Abbott Labs. But in a time of increased global manufacturing and troubles keeping an eye on supply chains, it’s a safe bet that poor supplier control is a culprit.
When FDA’s device center began piecing together a first-of-its-kind report to uncover recall trends, it expected to discover that products in their infancy would comprise most of the recalls in a given year.
After a few years of data analysis, however, the group within CDRH tasked with the research discovered, to their great...