Labs juggle string of LDT unknowns
July 2024—Like a long-awaited second act, the FDA’s final rule regulating laboratory-developed tests as medical devices took the stage this spring. As with any FDA performance, this one opened to mixed reviews.
The spring curtain-raising followed the earlier proposed rule from last October, which drew some 6,500 responses during the public comment period. If that was an out-of-town tryout, no one quite knew what to expect from the rewrite, or if there would even be one.
As it turns out, there were indeed changes, but they didn’t necessarily bring clarity. As Jane Pine Wood, counsel for McDonald Hopkins, puts it, the final rule “certainly raised a whole lot more questions than it answered.”
The rule calls for a four-year, five-stage phaseout policy with the FDA enacting greater oversight of in vitro diagnostic products that are offered as LDTs.
Stage one, beginning on May 6, 2025, calls for labs to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files.