The Institute of Medicine (IOM), which is the independent, non-profit health arm of the National Academy of Sciences, recently assembled a committee to study FDA's 510(k) clearance process for medical devices.    

The Committee will focus on two key questions: 1) Does the current 510(k) process optimally protect patient and promote innovation in support of public health? 2) If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process? The IOM Committee is expected to issue its report in mid-2011. 

As part of the Committee's study, on June 14-15 the IOM held a public workshop on the public health effectiveness of the FDA 510(k) clearance process.  Josh Makower, Consulting Association Professor of Medicine, Stanford University Biodesign Program, Founder & CEO, ExploraMed Development, LLC and NEA Venture Partner, was invited to make a presentation on the Structure of the Med Tech Innovation Ecosystem.

NVCA will continue to follow the actions of the IOM Committee reviewing the FDA 501(k) process.  The FDA Center for Devices and Radiological Health (CDRH) is also doing its own study on how to improve the regulatory process and plans to release their recommendations in September.  The NVCA has been meeting with CDRH senior staff and participating in stakeholder meetings, offering suggestions on how to improve the process.

We hope that a comprehensive review of the 510(k) framework may alleviate some of the current innovator frustration with the medical device review process.  NVCA believes that our recommendations will stimulate innovation and the development of novel technologies without compromising the safety or effectiveness of cleared or approved devices.