James Boiani Quoted in “What’s Next for LDTs? FDA May Be Eyeing a New Game Plan”

Medtech Insight

James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Insight, in “What’s Next for LDTs? FDA May Be Eyeing a New Game Plan.” (Read the full version – subscription required.)  

Following is an excerpt:

James Boiani, an attorney with the law firm Epstein Becker Green who specializes in diagnostic regulatory matters, suggests the agency could even decide to go in the opposite direction, where instead of making LDT regulation more like regulating IVDs, the agency could change its regulation of IVDs by creating a regulatory pathway that aligns more closely with LDT regulation.

"There have been proposals in the past to create additional pathways that would accelerate the development of IVDs, such as the transitional IVD approach," said Boiani.