Gottlieb Calls for New Legislative Authority for Diagnostics

The FDA will be looking for new authority to regulate diagnostics, Commissioner Scott Gottlieb said in a session on precision medicines at the World Economic Forum in Davos, Switzerland.

“I think it’s time that the agency needs to work with Congress and stakeholders to develop very specific targeted legislation that would give us a unique set of authorities to regulate diagnostics properly,” Gottlieb said.

“My view is that the old 510(k), PMA pathway…the traditional pathway for approving medical devices, doesn’t really fit well with modern diagnostics, and we need very well-fashioned authorities when it comes to diagnostics,” he added.

The agency will issue guidance for the design of precision medicine clinical trials that are steered more towards safety, off-target effects and long-term implications and durability. It will seek accelerated approval for precision medicines, designed to optimize efficiency or therapeutic benefit for particular groups of patients, especially by using genetic or molecular profiling, according to Gottlieb. — James Miessler