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Will Lab-Developed Test Makers Be Subject To Device Tax? It Depends, Shuren Suggests At Hearing

Lawmakers at a Sept. 9 House Energy and Commerce Subcommittee raised questions on whether FDA’s plans to regulate lab developed tests will also make labs subject to the device excise tax.

Congressional members questioned CDRH Director Jeff Shuren at a Sept. 9 hearing on whether a newly proposed regulatory framework

for lab developed tests unveiled by FDA July 31 will subject clinical laboratories to the 2.3 percent device excise tax.

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