Medical device consultants recognize that the US market is the largest in the world.
While FDA reports that the 510(k) refusal to accept rate (RTA) rate has declined in recent years, it is still too high and the reasons are largely preventable.
With proper planning and foresight, along with the right device consultant, RTA’s can be avoided and US 510(k) clearance can pave the way to relatively rapid entry into many other lucrative markets throughout the world.
As medical device consultants, PDG tend to take great interest in the premarket notification (510(k)) regulatory landscape.
Significant scrutiny has been given to the program over the last few years and the majority of legally marketed medical devices in the US today were cleared through the 510(k) regulatory pathway.
The 510(k) (as well as the IDE and PMA) came into existence with the passage of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act.
Enacted on May 28, 1976, this is also the law that established the Class I, II, and III, regulatory categories. The FDA established these categories to generally describe the scope of regulation needed to assure the safety and effectiveness of marketed medical devices.
To learn more about the background and current state of the 510(k) process, please feel free to download the white paper‘Medical Device Consultant on 510(k) Submissions.’ If you need immediate assistance with your 510(k), Health Canada or EMA submission, complete the information in the enquiry field to the right or give us a call at (813) 419-PDG1 (7341).