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As Device Recalls Hit The Stratosphere, FDA Asks Firms To Keep A Sharp Eye On Quality Systems

 
• By Shawn M. Schmitt

The US agency's national device expert is urging device-makers to take a hard look at their quality systems in the wake of a product recall. Phil Pontikos says firms must ask themselves "what broke down in your quality system to allow that to happen." His comments come as FDA grapples with an ever-increasing number of corrections and removals from device companies.

detailed illustration of a compass with Recall text, eps10 vector

US FDA is urging device-makers that initiate product recalls to take a hard look at their quality systems to determine why the problems weren't detected before the troublesome devices hit the market.

"From our perspective, what we see is that firms can identify the cause – or causes – of a failure, and then engage in CAPA [corrective and preventive action] activities....

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