According to the rule, manufacturers of LDTs must now follow certain requirements.
The FDA says it will exercise enforcement discretion for tests that were in use before May 6.
The FDAs final rule was contentious.
Bing Guan / Bloomberg / Getty Images
Others applauded the FDA, saying the step toward patient safety is long overdue.
Many of the diagnostic tests that are used are, in fact, laboratory-developed tests.
To test for other health factors, a provider may need to outsource.
Innovative lab tests have been developedto detect proteins, genetic mutations, and biological markers for various diseases.
This category only covers tests that are overseen by a clinician and doesnt includedirect-to-consumer testslike 23andMe genetic tests.
Thats an LDT, Lurie said.
When LDTs first appeared, they were less common, more specialized, and mostly served local populations.
FDA review,on the other hand,requires manufacturers to show that a test is clinically valid.
Clinicians put a lot of stock in the results of these tests.
Many of the first COVID-19 tests were created as LDTs.
The FDA isconsidering a policythat would allow laboratories to use unauthorized diagnostics during a public health emergency.
We will lose the expertise and the infrastructure, Landry wrote.
Over time, the results you receive from your medical tests may become more reliable.
Talk to your medical provider if you have questions about the results of a laboratory test.
Federal Register.Medical devices; laboratory developed tests: a rule by the Food and Drug Administration on 05/06/2024.
Food and Drug Administration.Laboratory developed tests: frequently asked questions.
