It’s Official: FDA Drops Final Rule On LDTs
Agency Provides Broad Exemption For LDTs Already On Market, Not For Academic Centers
After much anticipation, the US FDA is set to publish its controversial final rule for regulating laboratory developed tests, which places the tests under the same regulatory purview as other in vitro diagnostics. While the agency opted to include an exemption for LDTs already on the market, it did not provide an exemption for tests developed in academic medical centers.
