MedTech Dive October 21, 2024
Laboratories face a series of upcoming deadlines to comply with stricter FDA oversight of in-house tests. Here are five strategies labs can take to be ready.
Laboratories are just beginning to assess the magnitude of operational changes needed to comply with a new federal rule expanding regulatory oversight of lab developed tests (LDTs).
In a major shift, most tests designed by individual labs for in-house use must meet Food and Drug Administration requirements for medical devices under a final rule published in May. Those requirements, including adverse event reporting, premarket review, registration and labeling, will be phased in over the next four years.
Although the policy aims to improve the accuracy and reliability of LDTs, health industry groups warn the...
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