Thursday, 28 August 2014

FDA to begin regulating medical laboratory testing

The US Food and Drug Administration (FDA) has announced that it will begin regulating medical laboratory testing and will start with the issuance of draft guidelines in the next 60 days. The regulations will require that laboratory tests that were developed in-house in a clinical setting—so-called laboratory-developed tests (LDTs)—and direct-to-consumer diagnostic tests, such as DNA sequencing kits, secure FDA approval.

“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” FDA Commissioner Margaret Hamburg said in a statement. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”

The FDA said that the new regulations—which it will phase in over the next nine years—will focus on tests where an incorrect result could pose a high risk to patients.
Posted by Tim Sandle

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