NEW YORK (GenomeWeb News) — The US Food and Drug Administration has just released a draft guidance covering submission regulations for diagnostics developers seeking approval for Class III in vitro diagnostic devices.
The guidance proposes a set of updates that FDA believes would create a less burdensome regulatory path to approval for a previously approved or licensed assay that is being migrated for use with another system for which it has not been approved.
With the release of the draft guidance, “Assay Migration Studies for In Vitro Diagnostic Devices,” FDA has opened a public comment period during which interested parties may respond to its recommendations. FDA will take comments through April 6, 2009, after which it will begin working on a final version of the guidance.
The guidance reflects FDA’s review of relevant issues related to migration studies and what “we believe would be the least burdensome way of addressing these issues.
“FDA believes that with proper controls and review, migration studies will meet regulatory thresholds for pre-market review in a manner that will be least burdensome for both companies and FDA while protecting public health,” the agency said in the document.
The new methods would not apply to diagnostic systems that are intended for over-the-counter use, systems intended for prescription home use, or for devices that are intended for point-of-care use.
The guidance includes recommendations on a number of areas for submitters to consider, including qualitative and quantitative results, reproducibility studies, comparison panels, testing venues, analyte performance levels, statistical analysis information, and recommendations on other areas.
FDA also lays out specific criteria it deems unique to nucleic acid tests, and it said that such tests present specific concerns that are different from serological and antigen assays. Some of these criteria include suggestions about validating and controlling material and calibrators, sample stability, sample processing, and carryover studies.