Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Medical Device and Diagnostic Industry (MDDI), in “FDA’s Move on LDTs Is a Power Grab,” by Jim Dickinson.
Following is an excerpt:
Epstein Becker & Green attorney Bradley Merrill Thompson told the workshop that the LDT dilemma should be viewed in much the same way as FDA’s approach to pharmacy compounding—when does an LDT process merge into an IVD process that is regulated by the agency as manufacturing?
He suggested that FDA create a pharmacy compounding-like compliance policy guide to discern the difference between LDTs and IVDs made by industrialized laboratory companies that are manufacturing operations.
For example, Thompson continued, FDA could look at the equipment the lab is using and determine if it is engaged in processes that are more akin to manufacturing than lab services. FDA could also identify an already-available product on the market that the lab is mimicking that would make it an IVD and not an LDT, he explained.
“And you could look at the promotion,” Thompson said, adding that “FDA frequently goes after physicians engaged in the process of selling the use of medical devices (e.g. LASIK). FDA the last couple of years has gone after ophthalmologists for selling the procedure and over-promoting what LASIK can do. So FDA can look at the promotion of specific lab products instead of the services provided to discern the difference between legitimate lab services and IVD manufacturing, which would require FDA oversight.”
