FDAFinal Rule
Regulation Identification Number 0910–AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
Healthcare
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Summary
The FDA is reversing course on its previous attempt to regulate laboratory-developed tests (specialized medical tests created and used by individual labs). This rule removes the FDA's oversight requirements that were previously put in place, allowing labs more freedom in how they develop and offer these tests to patients and doctors.
Key Points
- 1The FDA is canceling its earlier rule that would have required laboratory-developed tests to get FDA approval before being used on patients
- 2This affects diagnostic tests created by hospitals, universities, and independent labs that were previously subject to less regulation than other medical devices
- 3Labs will have more flexibility in developing new tests without waiting for federal approval, which could speed up the availability of new diagnostic tools
- 4Doctors and patients may have access to more genetic and specialized tests more quickly, though without the same level of FDA quality oversight
- 5This change was triggered by a court decision (vacatur) that struck down the FDA's earlier regulatory requirement
Key Dates
Published
September 19, 2025
This summary is for informational purposes only. It may not capture all nuances of the regulation. Always refer to the official text for authoritative information.
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