A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.
Stakeholder input on FDA's draft Rx/Dx codevelopment guidance signals that precision medicine is actually developed differently than the agency wants it to be.
The FDA approved a slew of new drugs with companion and complementary tests, but the most talked about event was its decision to delay final guidance on LDTs.
The annual list includes guidelines that would clarify regulations for garnering premarket approval or clearance of devices and diagnostics, particularly next-generation sequencing tests.
More accommodating regulation and new funding may propel new diagnostics companies across the valley of death to commercial returns.
Mertz outlined the lab industry group's policy positions after FDA's decision to delay final guidance on regulation of lab tests and upcoming implementation of a payment law.
The guidance may be dead, but the issues underlying the controversy aren't, according to Gibbs, who said the agency can still take enforcement action against specific tests.
According to multiple sources in Washington, DC, the FDA has been informing stakeholders in policy circles of the decision.
During an FDA-sponsored workshop last week, participants discussed ideas for a regulatory framework that can evolve with rapidly advancing technology.