FDA revokes LDT rule

On March 31^st, the ruling for the Association for Molecular Pathology’s lawsuit against the U.S. Food and Drug Administration over the regulation of laboratory-developed test procedures was announced. The FDA has officially revoked their May 6, 2024 rule.

According to the new final rule, 21 CFR 809.3(a) will no longer say “including when the manufacturer of these products is a laboratory.” Instead, it will return to what it was before May 6, 2024.