The FDA’s loss in a district court lawsuit over the final rule for lab-developed tests (LDTs) was a watershed moment in the history of regulation of these tests, although the agency may yet appeal the decision. The outcome of the case, even if it stands, does not eliminate the FDA’s authority to indirectly oversee the...
The FDA’s final rule for regulation of lab-developed tests (LDTs) is likely to remain controversial for the foreseeable future, although Congress can still put those controversies to rest. In the absence of legislation, however, clinical labs will soon be subject to an entirely new set of regulatory requirements, drastically elevating the compliance risks for the...
The FDA draft rule for regulation of lab-developed tests (LDTs) is no radical departure from the Agency’s traditional regulatory scheme, but it would force clinical labs to conduct a major overhaul of their regulatory operations. There is still a debate as to whether the Agency is fully legally authorized to regulate LDTs, but there are other considerations which suggest the FDA’s timeline for this draft rule is highly ambitious.
There is a growing — and disconcerting — trend in which FDA resorts to regulation and lawmaking by fiat, overstepping the authority granted to it by Congress. Of particular concern are recent actions taken in regard to clinical decision support (CDS) software and laboratory-developed tests (LDTs).
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