Medical device consulting in the constantly changing landscape of the 510(k) review and clearance process has always been exciting.
The majority of legally marketed medical devices in the US were cleared through the 510(k) regulatory pathway. Further, the program has endured intense scrutiny and considerable change over the past few years.
In the summer of 2010, CDRH released a preliminary report recommending changes to the program.
By 2011, the Institute of Medicine (IOM) reported: "Stimulated by reports of problems with several 510(k) cleared devices, the public, legislators, the Government Accountability Office, the Department of Health and Human Services Office of the Inspector General, and the courts, including the Supreme Court, have all questioned the logic and value of the 510(k) clearance process being used by a federal agency charged with responsibility for protecting and promoting the public’s health.
"After 35 years, at a time of rapidly changing science and technology, questions persist about whether the 510(k) process is protecting and promoting the public’s health."
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).