Between a Political Rock and Industry Hard Place: The FDA's 510(k) Initiative

Waiting for the changes to the 510(k) process has left many in the medical device industry nervous. It has been a long process, with politicians, industry and the FDA itself weighing in. And we shouldn't have too much longer to wait for the Institute of Medicine's reveals its thoughts on the coming 510(k) revision.

FierceMedicalDevices has released a free eBook on the 510(k) process revisions that we hope will help readers understand the regulatory background to provide context for the issues at play. This eBook examines the FDA's 510(k) challenge, the motivations of the industry, FDA, Obama Administration and Congress, and advice on what steps medical device makers should take next to prepare for the coming changes. We've also compared modern-day medical devices to their (often barbaric) predecessors. While the 510(k) changes will be a challenge for the industry, seeing these early devices reminds us of how vital the FDA's device regulation is to ensuring public health. This ebook includes articles on:

  • The 510(k) Revision
  • The FDA's 510(k) Challenge
  • CDRH Regulation Timeline
  • A New and Improved 510(k) Process: Views of the Big 4 Influencers
  • The Political Perspective
  • Medical Devices through the Ages
  • What to Do Now

We hope you find this report to be interesting and informative. Click here for the free download. - Liz Hollis (twitter | email)