Flurries Of New Bills Advance Device Industry Interests In Congress
This article was originally published in The Gray Sheet
Executive SummaryThe first legislative salvos were launched last week in a battle that is sure to escalate in conjunction with device user fee reauthorization efforts next year.
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Despite failing to move on a bill to restrict FDA oversight of lab developed tests (LDT) or reintroducing the bill in recent sessions, Rep. Michael Burgess, R-Texas, says he still supports the idea and is still working on trying to limit the agency's authority.
Laboratory groups, who are facing the prospect of a new regulatory scheme in FDA’s proposed lab-developed test framework, intend to discuss barriers to test accessibility and clinical validation of LDTs.