FDA Shift on Diagnostics Lays Groundwork for Regulation of Lab-Developed Tests

Global Life Sciences - U.S. FDA Update

On July 12, 2011, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) announced plans to down-classify and exempt from Section 510(k) premarket notification a range of in vitro diagnostic and radiology device types. In a draft guidance for industry, FDA promised to amend the classification regulations for the devices, and in the interim decline to enforce Section 510(k) for those products.

The draft guidance identifies devices in more than two dozen classifications that will no longer be subject to premarket notification. The affected products include common urine and blood tests, alcohol breath tests, blood clotting protein tests, and radiology device accessories. The draft states that the devices “have established safety and effectiveness profiles” and premarket review is “not necessary to assure safety and effectiveness.”

The draft moves FDA one step closer to active regulation of laboratory developed tests (LDTs). In July 2010, FDA held a public meeting announcing its intention to regulate LDTs—which have long been outside FDA’s’ purview—by issuing guidance. At that meeting, an OIVD official stated that, to free up resources necessary for LDT regulation, OIVD would consider down-classifying some devices already subject to FDA control. The new enforcement policy is therefore consistent with FDA’s previously announced objectives with respect to LDTs, and reflects OIVD’s continued commitment to the active regulation of clinical laboratory testing.

The draft guidance is available here.

Comments must be submitted to FDA by October 10, 2011.

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