14 December 2017 - In recent days, the FDA has committed to several new policies that will modernise the agency’s approach to regulation in the medical device system.

For instance, we announced our intention to propose an alternate approach to the traditional 510(k) clearance process, which will involve the use of modern, science-based, consensus standards and FDA-developed performance criteria as the comparator for device review for certain well-understood technologies. 

FDA currently compares new devices to predicate devices that can in many cases be as much as 40 years old. By modernising the standards that FDA uses to assess some new devices, it will make it easier to innovate these products, and adopt more up-to-date and rigorous benchmarks for evaluating their safety and effectiveness.

Read FDA blog