Ensuring Quality is the best first step any company, especially startups, can take steps toward preparing for future changes to LDT regulations. Hire and lean on your quality expert to formalize documents to meet requirements, find gaps in best practices, and utilize internal audits to verify standards are being followed.
With the projection that the U.S. may spend up to $27.9 billion annually on low-value screening, testing, and procedures considered waste, there needs to be a new approach to how the lab industry develops test menus from which physicians order labs.
Greenway Health blends smart technology with human expertise to elevate revenue cycle.
FDA approval would set a molecular test apart, said Vince Miller, Foundation Medicine’s chief medical officer. “CLIA is the floor, New York State is a number of floors above that and the FDA is the penthouse.”
At a medtech industry conference, the FDA Commissioner forcefully called for legislation to regulate the lab-developed testing industry and said he is speaking to lawmakers on Capitol Hill.
FDA is delaying finalizing its regulation of lab-developed tests, but in the meantime continued FDA enforcement discretion will be the norm as will its issuing of enforcement letters.