FDA Lab Test Authority Set for Compliance Hurdles, Legal Fights

The FDA’s final rule to regulate lab-developed tests carved out certain diagnostics from its full scrutiny, creating exceptions that are spurring compliance concerns from some industry members.

The Food and Drug Administration on May 6 published in the Federal Register its 160-page rule that gives it explicit authority to regulate certain medical tests that come from a single laboratory, known as lab-developed tests (LDTs). The rule makes clear that in vitro diagnostics (IVDs) include tests manufactured by a laboratory under the Federal Food, Drug, and Cosmetic Act. The regulation also laid out a five-stage phaseout plan over a four-year period ...