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Recall Effectiveness Checks: FDA Tips

 
• By Shawn M. Schmitt

Conducting device recall effectiveness checks can be tricky. Two FDA officials offer advice to make the process work smoother and explain why Unique Device Identification will be helpful in this month’s “Compliance Corner.”

The lynchpin of a good product recall effectiveness check is ensuring adequate documentation, an FDA recall coordinator says.

Effectiveness checks happen when companies contact product users to make sure they know that a recall is underway. They also...

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