The group of regulatory authorities from around the world has proposed a new guidance for harmonizing the procedures for assessing medical devices, including IVDs.
The FDA's draft document noted that it is providing additional clarity to help itself and manufacturers better apply the concepts in a 2003 guidance document.
While stakeholders hope that the country will continue to accept the CE-IVD mark after Brexit, the issue is unresolved, leaving firms in the dark as to what the future may bring.
Companies are now expected to have their tests cleared by authorities for clinical use, and to bring their entire catalogs into line with the new regulations by May 2022.
The updated guidance comes on the heels of new data suggesting that for some individuals, antibodies to the Zika virus may stay in the body for months after infection.
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.