Stacy Amin authored an article for Law360 discussing the proposed rule of the U.S. Food and Drug Administration (FDA) to regulate laboratory-developed tests and what to expect if it is finalized.
“The proposed rule would finally clarify that the FDA can and will regulate laboratory-developed tests, or LDTs, as any other medical device. When finalized, the rule could spark the most significant litigation the agency has faced in over 20 years, with ramifications far beyond laboratories,” Stacy explained. “For decades, the FDA has exercised what it calls enforcement discretion with respect to most LDTs, i.e., it generally has not enforced regulatory requirements with respect to most in vitro diagnostic products designed, manufactured and used within a single laboratory.”
Read the full article.