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.
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.