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FDA Reminds Diagnostics Makers Of Rules On Research Using Human Specimens

 
• By Elizabeth Orr

Even research using leftover, deidentified specimens must be reviewed by an IRB, the US agency said in a letter to industry.

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Diagnostic test developers who conduct clinical research using any human samples – including leftover, deidentified specimens – must get clearance from an Institutional Review Board (IRB), the US Food and Drug Administration said in an 18 October letter to industry.

The letter, which was signed by William Maisel, director of the device center’s Office of Product Evaluation and Quality, notes...

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