FDA, Device Lobby, Pathology Group Debate Regulation Of Laboratory Testing

Representatives from a major pathology association, the largest lobbying group for medical device manufacturers and FDA faced off last week over the agency’s draft guidance on laboratory developed tests, a discussion that underscored the fierce debate among stakeholders as to the level of oversight required to ensure the safety and accuracy of tests performed in laboratories. The director of in vitro diagnostics at the FDA also touched upon the agency’s regulation of next-generation sequencing, acknowledging the agency does not have...