This week, we learned that FDA’s final rule on laboratory developed tests (LDTs) may soon see the light of day.
On Monday the Office of Management and Budget (OMB) announced it had completed its review of the final rule. The controversial proposed rule, which was published in September 2023, has faced opposition from test developers and medical centers, while the medical device industry has backed greater FDA oversight of such tests.
The measure has also drawn much debate in Congress when in late March, members of the US House Energy and Commerce (E&C) health subcommittee sparred over whether the FDA was within its right to develop a rule to regulate LDTs. Republicans were largely opposed to these products being regulated by the agency, while Democrats argued the agency was left with no alternative after Congress failed to pass the Verifying Accurate, Leading-edge IVCT Development (VALID) Act.
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