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Third-Party Labs May Produce False Data, FDA Warns

 
• By Elizabeth Orr

The US agency is warning manufacturers about an alarming device submission trend toward unreliable data generated by third-party labs.

Gloved hand holding beaker with green and yellow liquid inside.
• Source: Shutterstock

Device firms that hire third-party companies to conduct performance testing may get less than they’re paying for, the US Food and Drug Administration says in a new letter to industry.

The 20 February alert directs manufacturers and other sponsors of device studies to “carefully evaluate” third-party labs and independently verify all testing results before they are included in regulatory submissions....

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