FDA to Modernize 510(k) Program

FDA Commissioner, Scott Gottlieb, recently announced plans to update the FDA's 510(k) pathway for approving new medical devices.  The new plan emphasizes a need to be less reliant on older predicate technologies, and may publish when an applicant uses a predicate more than 10 years old.

"We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria."

Read the full press release here.