New FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works.
In 2018, FDA cleared 3,000+ medical devices via the 510(k) process. An overwhelming majority of those devices (82%) went through the Traditional 510(k) process. Only 60 (less than 2%) went through the alluring “Abbreviated 510(k)” process. Why? Well, frankly there is very little that is “abbreviated” about that process, as it still requires the submitter to demonstrate “substantial equivalence” to a suitable predicate device. Now, however, FDA has finally done something to provide relief from this requirement – it released a new […]» Read more