The U.S. Food and Drug Administration released a notice to Congress announcing the agency’s intent to release a draft guidance providing a framework for bringing laboratory developed tests under FDA’s regulatory authority.
On July 31, the Food and Drug Administraiton released a notice to Congress announcing the agency’s intent to release draft guidance proviidng a frameowkr for bringing laboratory developed tests under the FDA’s regulatory authority.
The FDA notice included a copy of the draft guidance, which is expected to be released for comment on or after September 29. To read the draft guidance, click here.
