Could the FDA take an indirect approach to regulate LDTs?

Could the FDA take an indirect approach to regulate lab developed tests?

Attorneys said many questions remain about test regulation after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

Could the FDA take an indirect approach to regulate LDTs?

Attorneys said many questions remain about the regulation of laboratory developed tests after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

Could The FDA Take An Indirect Approach To Regulate LDTs? - Data Intelligence

Listen to the article 7 min This audio is auto-generated. Please let us know if you have feedback. When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a word from the agency, industry groups were relieved that the plan they sued to stop was dead. The U.S. District Court for the Eastern District of Texas found …